All Practice Exam Final

Your company's commercial product is manufactured by a third-party manufacturer (TPM). The manufacturing site undercharges one of the excipients. Without contacting your company, the TPM decides to rework the batch and now would like the product to be released upon completion of the investigation. Your technical team contacts you for regulatory advice on whether the lot can be released upon approval of the investigation. As a regulatory professional, as a first step you: A. Recommend that the lot be released B. Recommend that the lot not be released C. Assess whether the rework steps are within the regulatory filing and whether there is a potential regulatory impact D. If the rework steps are not in the current filing, submit a postapproval change to include the rework steps in order to release the material

C. Assess whether the rework steps are within the regulatory filing and whether there is a potential regulatory impact The release and disposition of product is a quality responsibility, not regulatory. The regulatory professional is responsible for reviewing the event and assessing whether the additional steps performed in the manufacturing process are allowed within the regulatory filing. The team may decide to include the rework procedure; however, additional data may be needed for the submission. Therefore the recommended first step is response 3.

Your company's commercial product is manufactured by a third-party manufacturer (TPM). The manufacturing site undercharges one of the excipients. Without contacting your company, the TPM decides to rework the batch and now would like the product to be released upon completion of the investigation. Your technical team contacts you for regulatory advice on whether the lot can be released upon approval of the investigation. As a regulatory professional, as a first step you: A. Recommend that the lot be released B. Recommend that the lot not be released C. Assess whether the rework steps are within the regulatory filing and whether there is a potential regulatory impact D. If the rework steps are not in the current filing, submit a postapproval change to include the rework steps in order to release the material

C. Assess whether the rework steps are within the regulatory filing and whether there is a potential regulatory impact The release and disposition of product is a quality responsibility, not regulatory. The regulatory professional is responsible for reviewing the event and assessing whether the additional steps performed in the manufacturing process are allowed within the regulatory filing. The team may decide to include the rework procedure; however, additional data may be needed for the submission. Therefore the recommended first step is response C.

Which one of the following is not true regarding the "Regulatory Review Period" for Patent term extension: A. Regulatory review period is composed of "testing phase" and "review phase" B. Sum of half of the time of the testing phase + all the time in review phase C. Begins on the effective date of an IND and end on the date of submission of NDA D. The total calculated regulatory review period may not exceed 5 years and extended patent term may not exceed 14 years.

C. Begins on the effective date of an IND and end on the date of submission of NDA Begin on submission of NDA

When assembling an NDA, all of the following are required EXCEPT: A. Proposed labeling. B. Nonclinical toxicology studies. C. Bioequivalence studies. D. Manufacturing information.

C. Bioequivalence studies. Bioequivalence data is required in an ANDA, not a NDA, see 21 CFR 314.94(7).

Your company is planning to market an allergen patch test. Which center should oversee the review process? A. CDER B. CDRH C. CBER D. CTP

C. CBER

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP

C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case.

Which division would have a primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER. B. CBER. C. CDRH. D. OCP.

C. CDRH.

Which division would have a primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER. B. CBER. C. CDRH. D. OCP.

C. CDRH. In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case.

Which is not a division of the FDA? A. CDRH B. CDER C. CFER D. CVM

C. CFER

An applicant is required to submit patent information when approval is sought in which of the following supplements submitted to an approved marketing application? A. Change in the packaging B. Change in manufacturing site C. Change in the formulation D. Change in product labeling

C. Change in the formulation An applicant is required to submit patent information when approval is sought in supplements involving a formulation change, a new condition of use, a new indication, a change in the route of administration, a change in strength or any other patented change regarding the drug, drug product or method of use.

According to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in procedures correcting quality problems D. Any reply to the complainant

C. Changes in procedures correcting quality problems The requirement is for corrective and preventative action and only needed if a corrective action was taken as a result of the investigation. See Sec. 820.198. Complaint Files.

A deficiency letter may be issued to a company during review of a Biologics License Application (BLA) for which of the following? (A) Clinical testing did not include enough subjects. (B) The BLA was not submitted electronically. (C) The sponsor failed to have a meeting with FDA prior to submitting the BLA to discuss the product and clinical testing plan. (D) The submission did not include a Drug Master File (DMF) with information about facilities and processes used in manufacturing

(A) Clinical testing did not include enough subjects.

A company's competitor is marketing a Class II suture that dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving times as the competitor's. What needs to be done for the company to market this new dissolving suture? A. Filing a new 510(k) documenting changes in product instructions for use B. Submission of changes in a periodic report C. After reporting clinical studies in an Annual Report D. After submission of labeling change

(A) Filing a new 510(k) documenting changes in product instructions for use Regulatory Reference: 21 CFR 807. A new intended use requires a 510(k).

An investigator wishing to begin a clinical investigation using xenotransplantation must submit the following: (A) IND (B) 505 (b) (2) (C) BLA (D) INAD

(A) IND

According to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in procedures correcting quality problems D. Any reply to the complainant

C. Changes in procedures correcting quality problems The requirement is for corrective and preventative action and only needed if a corrective action was taken as a result of the investigation. See Sec. 820.198. Complaint files.

Your company recently gained approval for a novel biologic drug to treat a rare disease that has no other known therapy. The demand for your compound is several times what was anticipated and you are running into a supply issue due to the scarcity of a manufacturing component. Which manufacturing license strategy would immediately help to address the supply shortage. (A) Obtain the initial and partially-manufactured version of the product from unlicensed facilities (B) No immediate action is necessary until you expand your own manufacturing capabilities next year (C) Share manufacturing between several manufacturers that are registered and licensed for specific aspects of the product's manufacturing process (D) Utilize a contract manufacturer where your company will hold the license and the contract facility will be under your control

(A) Obtain the initial and partially-manufactured version of the product from unlicensed facilities

Blood Center ABC has just opened in a Midwestern state. It plans to manufacture blood and blood products from volunteer blood donors and offer these products for sale to local dialysis clinics and hospitals in other states. Blood Center ABC must: (A) Register with FDA within five days after beginning operations and provide a current product list of all products manufactured, prepared, processed and distributed (B) Wait to distribute any blood products until the successful completion of a GMP inspection by FDA (C) Submit an NDA to FDA prior to distribution of any blood products in interstate commerce (D) Submit a label supplement to FDA prior to distribution of any blood products in interstate commerce

(A) Register with FDA within five days after beginning operations and provide a current product list of all products manufactured, prepared, processed and distributed

Which of the following states is NOT true with respect to both Investigational New Drug (IND) Applications and Inverstigational Decice Exemptions (IEDs) for significant- risk products? A. The investigational product must be manufactured in full compliance with CGMP B. Clinical studies must be reviewed and approved by an Institutional Review Board C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise. D. The application must include and environmental impact statement that contains a claim for categorical exclusion or and environmental assessment

(A) The investigational product must be manufactured in full compliance with CGMP. Devices under approved IDEs are exempt from CGMP regulations except for design control requirements; investigational new drugs must be compliant with CGMP for finished pharmaceuticals. Regulatory Reference: 21 CFR 211.

A company plans to develop a new treatment for anemia. The product is a polypeptide fragment of the human protein erythropoetin that has not been previously approved. The company plans to produce the polypeptide by chemical synthesis. To date, other erythropoetins have been approved by FDA, but not the fragment. What is the appropriate pathway by which to seek approval? (A) Under Section 505 (b) (1) of the FD&C Act (B) Under Section 505 (b) (2) of the FD&C Act (C) Under Section 351 (a) of the PHS Act (D) Under Section 351 (k) of the PHS Act

(A) Under Section 505 (b) (1) of the FD&C Act

Your company is planning to market an allergen patch test. Which center should oversee the review process? (A) CDER (B) CBER (C) CDRH (D) CTP

(B) CBER

Which of the following is NOT required in a Biologics License Application (BLA) but is required in a New Drug Application (NDA)? (A) FDA form 3397 (user fee cover sheet) (B) Field copy certification (C) Chemistry section (D) Debarment certification

(B) Field copy certification

Your company recently submitted a Biologics License Application (BLA) to CDER and the review division the has notified the company that it must develop and submit a Medication Guide. This request may have resulted from any of the following EXCEPT: (A) The product is one for which patient labeling could help prevent serious adverse effects (B) The product is one in which it has been demonstrated through adequate and well-controlled trials to be less effective than alternative therapies (C) The drug product is one that has serious risk(s) relative to benefits of which patients should be made aware because information concerning the risks could affect patients' decision to use, or continue to use the product (D)The product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness

(B) The product is one in which it has been demonstrated through adequate and well-controlled trials to be less effective than alternative therapies

Pharmacogenomic testing data results must be submitted to an IND in all the following circumstances EXCEPT: (A) The test results will be used to support safety of the product. (B) Animal test results will be used to support safety of the product. (C) Data were derived from general gene-expression analysis of trial participants. (D) Test results constitute a known valid biomarker for toxicologic outcomes in human

(C) Data were derived from general gene-expression analysis of trial participants.

The following biological products are regulated by CBER EXCEPT? (A) Immunizing toxoids (B) Monoclonal antibodies for in vitro use (C) Monoclonal antibodies for in vivo use (D) Infusion of animal sourced cells into a human

(C) Monoclonal antibodies for in vivo use

A PMA submission contains all of the following except: A. Clinical Trials results B. Stability data C. Cost of manufacturing of the device D. Data from remaining toxicity and carcinogenicity studies

C. Cost of manufacturing of the device

Pharmacogenomic testing data results must be submitted to an IND in all the following circumstances EXCEPT when: A. The test results will be used to determine dosing schedule selection in a clinical trial B. The test results will be used to make decisions in an animal trial used to support safety C. Data were derived from general gene-expression analysis of trial participants D. Test results constitute a known valid biomarker for toxicologic outcomes in humans

C. Data were derived from general gene-expression analysis of trial participants Exploratory data or research data are not required to be submitted, but are welcomed as a voluntary submission of the data in a VGDS (voluntary genomic data submission).

Which of the following is considered part of the Device Master Record? A. Employee training record B. Serial number label C. Design reviews D. Calibration records

C. Design reviews

Adverse biological event reporting is consistent to which of the following? A. Vaccines products regulated by CBER B. Blood product regulated by CBER C. Drug products regulated by CDER D. Medical Device products regulated by CDRH

C. Drug products regulated by CDER

A humanitarian device exemption (HDE) differs from a traditional PMA in that: A. It does not require compliance with QSR. B. Non-clinical data are not required. C. Effectiveness data are not required. D. Device characteristics are not required.

C. Effectiveness data are not required.

A humanitarian device exemption (HDE) differs from a traditional PMA in that: A. It does not require compliance with QSR. B. Non-clinical data are not required. C. Effectiveness data are not required. D. Device characteristics are not required.

C. Effectiveness data are not required. See Section 520 ((m) of the FD&C and 21 CFR 814.104(b)(4).

During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical investigation without obtaining informed consent from the subject. Which of the following should the regulatory affairs practitioner do? A. Predate the informed consent with a memo to the site file B. Contact the patient to obtain the informed consent immediately C. Ensure that the study director from the sponsor discuss the issue with the investigator D. Report the protocol deviation to the IRB

C. Ensure that the study director from the sponsor discuss the issue with the investigator A. Consent forms should never be pre- or post-dated. B. This is the responsibility of the investigator. C. [per 812.150(a)(5) and (b)(8)] D. This is the responsibility of the investigator [per 812.150(a)(5)].

A Drug Master File may be used for any of the following purposes EXCEPT: A. Supplemental information on the drug product or drug substance B. Supplemental information for any type of submission to the agency C. FDA approval of the Drug Master File D. Incorporation by reference all or part of the contents of any Drug Master File in support of a submission when the holder has authorized the incorporation in writing

C. FDA approval of the Drug Master File FDA does not approve or disapprove Drug Master Files; it only reviews them as supplemental information. Sec. 314.420 Drug master files. FDA ordinarily neither independently reviews drug master files nor approves or disapproves submissions to a drug master file.

Notice of Intent to Revoke license can be issued by CBER for the following reasons, EXCEPT: A. Unable to gain access to the manufacturing facility after reasonable efforts for an inspection B. Licensed products are no longer safe and effective for intended use C. Failure to report serious adverse event D. Manufacturer fails to conform to applicable standards to ensure product safety, potency and purity

C. Failure to report serious adverse event Answers A, B and D are reasons to issue Notice of Intent to Revoke license. Answer C is a postapproval reporting issue (21 CFR 606.170(b)).

Which government agency has the responsibility for regulating cosmetic advertising? A. Food and Drug Administration (FDA) B. National Advertising Division (NAD) C. Federal Trade Commission (FTC) D. Department of Commerce (DOC)

C. Federal Trade Commission (FTC)

During the open-label extension phase of a clinical trial for NEWDRUG, some new and different adverse events occurred that could affect the final labeling. The NDA for NEWDRUG was submitted six weeks ago. What is the best way to notify FDA of these adverse events? A. Medwatch form 3500A B. 100 day review C. Four-month update D. Response to FDA request for information

C. Four-month update Section 505(i) requires an NDA update four months after the initial submission—entitled "safety update report" by the code—which would affect the contraindication, warnings, precautions and adverse reactions sections of the draft labeling.

During the open-label extension phase of a clinical trial for NEWDRUG, some new and different adverse events occurred that could affect the final labeling. The NDA for NEWDRUG was submitted six weeks ago. What is the best way to notify FDA of these adverse events? A. Medwatch form 3500A B. 100 day review C. Four-month update D. Response to FDA request for information

C. Four-month update Section 505(i) requires an NDA update four months after the initial submission—entitled "safety update report" by the code—which would affect the contraindication, warnings, precautions and adverse reactions sections of the draft labeling.

Which of the following devices would be regulated by CBER? A. Warming device B. Blood pressure cuff C. HIV diagnostic test kit D. Capillary blood collection tube

C. HIV diagnostic test kit After the departure of therapeutic biological products to CDER, CBER was left with the rest which essentially amounts to blood and related products, vaccines and gene therapy, some devices and diagnostic test kits. In the test question, I tried to distract you by putting blood into several of the responses because when I hear blood, I think CBER. The key words are HIV (read blood related) and diagnostic test kit Thus, C is the best answer A) Incorrect - regulated by CDRH B) Incorrect - regulated by CDRH C) Correct - in vitro diagnostic D) Incorrect - regulated by CDRH

For an Investigational New Drug entering a six-month phase III trial, which of the following non-clinical studies is/are not necessary to have been completed? I. carcinogenicity studies II. long-term toxicity studies III. Pre and post-natal development A. I only B. II only C. I and III

C. I and III A. not necessary to be completed, should be in progress B. Long-term toxicity studies must be complete to initiate six-month study. C. not necessary to be completed, should be in progress D. See explanation B.

FDA will generally grant a waiver of in vivo bioequivalence testing for which of the following generic drug products? A intravenous injections B. antibiotic suspensions C. intramuscular injection D. uncoated tablets

A intravenous injections A. The in vivo bioequivalence of an approved drug which is administered intravenously is self evident and does B. Orally administered products may vary in bioequivalence and, therefore, it is not self evident. C. Intramuscularly administered products may vary in bioequivalence and, therefore it is not self evident.

Which of the following is an example of a "Changes Being Effected" supplement? A) Add/strengthen a contraindication, warning B) Change in specifications to comply with an official compendium C) Editorial change D) Deletion or reduction of an ingredient to affect color

A) Add/strengthen a contraindication, warning CBE-0 - Changes being effected immediately Changes being effected -Add/strengthen contraindication, warning, precaution, adverse reaction -Instruction about dose intended to increase safe use of product -Delete false or misleading, or unsupported indications, or claims of effectiveness Annual Report -Delete/reduce ingredient to affect color -Changes to comply with official compendium -Editorial change to label

If your firm commercially distributes a Class III device that is subject to PMA requirements without an approved Pre-market Approval Application, what is the statutory violation? A) Adulteration B) Improper Use C) Misbranding D) Idiocy

A) Adulteration

Which is a type of administrative enforcement tool that FDA may use outside of the US court system or the Department of Justice? A) Application Integrity Policy B) Seizure C) Injunction D) Disgorgement

A) Application Integrity Policy Administrative enforcement tools are those that FDA may initiate without using the US court system or the assistance of the Department of Justice. Judicial actions involve the US court system of Dept of Justice Items B, C, D are examples of judicial enforcement tools Item A, Application Integrity Policy is essentially a policy against fraud... false information submitted to FDA either through deliberate mis-statement or a pattern of sloppiness or inaccuracy. One of the possible results is an interruption or suspension of application review, if FDA determines the data may not be credible or reliable. AIP is Invoked by the Center Director. Injunction: FDA customarily names the company and one or more individuals as defendants. The case is filed in U.S. District Court. Grants FDA power to inspect facilities at your expense and to shut down operation and dispose of goods. Seizure warrant: warrant for the arrest of property from judge or magistrate in US Federal Court Goods usually seized by US Marshals, accompanied by FDA agents or investigators Disgorgement is a payment that is calculated on ill-gotten profits, ie, from noncomplicance. Disgorgement is frequently required under a consent decree. Consent decrees are associated with injunctions which involve the court or justice system

Which of the following is typically included in a reminder advertisement? A) Brand and generic names B) Indication(s) C) Dose information D) Statement of efficacy

A) Brand and generic names Reminder ads: Disclose name of product, may provide dosage form (tablet, capsule, syrup) but may not state indication or make claims (not allowed for products with "black box" warnings) May contain: Brand and generic names of the product Established name of the active ingredients Optional: -Quantitative ingredient statements -Dosage form -Quantity of package contents -Price -Name and address of manufacturer, packer or distributor May NOT contain written, printed, or graphic matter containing representations or suggestions relating to the advertised drug product Cannot use reminder ad if have black box warning in prescribing information

Dental floss is an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device

A) Class 1 Class 1 (Exempt from pre-market notification procedure) Sec. 872.6390 Dental floss. - Identification. Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use. - Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 872.9.

A company is planning to implement a few minor manufacturing changes for its FDA-approved device. The company is currently conducting a clinical study for a new indication using this device. The correct submission for the regulatory professional to make is the: A. PMA Amendment B. IND Supplement C. IDE 5-day Notice D. CBE-30

C. IDE 5-day Notice IND Supplements and CBE-30 submissions are for drugs. A PMA amendment includes all additional submissions to a PMA or PMA supplement before approval of the PMA or PMA supplement or all additional correspondence after PMA or PMA supplement approval. During the conduct of a clinical study for a device, if minor manufacturing changes are made, these changes can be reported to FDA in an IDE 5-Day Notice.

A non-powered microsurgical instrument for use in neurological microsurgery procedures is an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device

A) Class 1 Class 1, exempt from premarket notification Sec. 882.4535 Nonpowered neurosurgical instrument. - Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc. - Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 882.9.

Non-prescription sunglasses are an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) No way is this a device

A) Class 1 Class 1, exempt from premarket notification Sec. 886.5850 Sunglasses (nonprescription). - Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter. - Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

The Quality System Regulation for Class III devices applies to the following except: A) Critical component manufacturers B) Operations done by the manufacturer at facilities located in the United States C) Research on investigational devices tested outside of the United States D) Contract Sterilizers

A) Critical component manufacturers A "component" is defined by 21 CFR 820.3 (c) as "any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device."

If FDA were to invoke the Application Integrity Policy, which of the following is a possible outcome? A) Defer review of pending application(s) B) "File" a marketing application at the 60 day review C) Grant a waiver or deferral for pediatric clinical study D) Approve a marketing application

A) Defer review of pending application(s) The AIP may be invoked in cases where fraudulent data, such as untrue statement of fact, false statement, omission, has been submitted to the Federal Government. This could be either deliberate due to a pattern of sloppiness or an intentional act and could be a pattern or practice that may occur in one or more applications.

FDA currently requires that all medical device registration and listing information (Annual, Initial or Updates) be submitted using: A) FDAs Unified Registration and Listing System B) FDA Forms 2891 and 2892 C) FDA Forms 2656 and 2657 D) FDA Form 3356

A) FDAs Unified Registration and Listing System (FURLS) According to the FDA website, the Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver. Furthermore, registration and listing information need to be submitted by using FDA's Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM). This question tests whether the examinee's knowledge on medical device establishment registration and listing is current. Only Choice ID #1 is correct. The other answers are distracters. Regulatory Reference: FDA Website: How to register and list medical device (http:/www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm).

When an FDA inspector arrives at a facility, he or she must present is: A) Form FDA 482 and credentials B) EIR C) Form FDA 483 and Notice of Inspection D) Form FDA 484

A) Form FDA 482 and credentials -Form FDA 482 - Notice of inspection, presented on arrival with credentials (identification) of investigator -Form FDA 483 - List of observations, presented at close of inspection Form FDA 484 - Receipt for samples -EIR - Establishment Inspection Report -Includes forms issued during inspection (e.g., 482, 483, 484) -Investigator's narrative report which provides supportive details to observations documented on FDA-483

For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment? A) Report adverse events under the Medical Device Reporting regulation B) Assisting FDA in communications with the foreign establishment, C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and D) Assisting FDA in scheduling inspections of the foreign establishment.

A) Report adverse events under the Medical Device Reporting regulation

For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment? A) Report adverse events under the Medical Device Reporting regulation B) Assisting FDA in communications with the foreign establishment, C) Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and D) Assisting FDA in scheduling inspections of the foreign establishment.

A) Report adverse events under the Medical Device Reporting regulation The US agent has no responsibility to report adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or to submit Pre-market Notifications [510(k)] (21 CFR Part 807, Subpart E) All foreign establishments must notify FDA of the name, address and phone number of their United States agent -Agent must either reside in the U.S. or maintain a place of business in the U.S. -The US agent cannot use a post office box as an address. -The US agent cannot use an answering service. -The agent must be available to answer the phone or have an employee available to answer the phone during normal business hours.

Your company is developing a product to treat a serious and life threatening disease. A clinically meaningful, well-established primary endpoint will be used in the pivotal studies. Which regulatory strategy might you select prior to commencing Phase 3 studies? A) Request Special Protocol Assessment B) Request Fast Track Designation C) Request Priority Review D) Approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses

A) Request Special Protocol Assessment A) Special Protocol Assessment is the best choice, this option applies to Phase 3/pivotal studies and the time to request such an assessment would be prior to commencing the study. Not D because Subpart H is based on surrogate endpoints, ie, something not well established Eliminate C) Priority review since this would be requested when you submit the marketing application, not prior to Phase 3 studies B) Fast Track Designation may seem an OK choice; however, you can request FT designation at any time so this isn't the best choice.

The following are characteristics of FDA GMP inspections EXCEPT: A) Results of internal audit findings are required to be provided to the FDA Inspectors upon request B) Biennial inspections of manufacturing facilities take place to verify compliance with regulations. C) The FDA may inspect the drug product sponsor and any manufacturing subcontractors. D) FDA inspections may be conducted due to serious non-compliance with GMP regulations

A) Results of internal audit findings are required to be provided to the FDA Inspectors upon request FDA can request SOPs and other supporting information to confirm a process for conducting internal audits. Actual written audit reports are not shared with FDA during an inspection. Actual written audit reports are not shared with FDA during an inspection.

You, a regulatory affairs professional, are in a situation where an administrative or procedural dispute has occurred between the sponsor and the FDA reviewing division. In attempt to resolve the dispute, on what level would you initially try to resolve the dispute? A) Review Division B) Agency Ombudsman C) Office Director D) FDA Office of Regulatory Affairs

A) Review Division Procedural and administrative disputes: first attempt to resolve procedural and administrative disputes within the reviewing division, starting with the Project Manager Scientific dispute: start with supervisory level of individual who made decision and increase levels as necessary Office of the Ombudsman: A resource in cases where sponsor is experiencing problems with the regulatory process or with the application of FDA policies or procedures

Which of the following examples best represents "fair balance"? A) Risks and benefits are presented in comparable prominence, readability B) A reminder ad C) Established name appears next to brand name in type at least 50% of brand name D) Advertising directed to physicians and consumers

A) Risks and benefits are presented in comparable prominence, readability Fair Balance Between information relating to side effects, contraindications, warnings, and precautions vs. Information related to Effectiveness Contextual Fair Balance: Comparable scope, depth and detail - 21 CFR 202.1(e)(5) Physical Fair Balance: Reasonably comparable prominence and readability, accounting for typography, layout, white space, etc. - 21 CFR 202.1(e)(7)(viii)

Pre-market Notification Requirements would apply to a device that is: A) Substantially equivalent to a pre-amendment device B) Intended solely for use by a specific physician C) Not equivalent to currently marketed devices D) Intended for veterinary use

A) Substantially equivalent to a pre-amendment device Premarket Notification Requirements apply to: -New medical devices that are not: 1. Exempt (most Class I and some Class II) 2. Custom devices (FD&C Act § 520(b) and 21CFR 812.3(b)) 3. Subject to PMA requirements (most Class III) -Medical devices already cleared by FDA if: 1. New intended use 2. Significant modifications in design, materials/composition, specifications, labeling 3. New "sponsor" who has not legally acquired rights to the original 510(k)

When design verification testing is being performed by a manufacturer, which element is NOT included as a potential requirement under device design verification section of the QSR? A. Identification of the design. B. Software validation. C. Identification of test methods used. D. Name of individuals performing the testing.

C. Identification of test methods used.

Your company wishes to seek approval of a combination of individually approved anti-hypertensive and anti-diabetic drugs. However, there is no Reference Listed Drug (RLD) for the proposed combination. Which of the following regulatory pathways is most applicable? A. 505(b)(2) B. 510(k) C. 505(b)(1) D. 505(j)

A. 505(b)(2) A 505(b)2 NDA relies at least in part on data that is not developed by the applicant. Reference listed drug means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application. Section 505 of the act describes three types of new drug applications: (1) an application that contains full reports of investigations of safety and effectiveness (section 505(b)(1)); (2) an application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference (section 505(b)(2)); Section 505(b)(2) was added to the act by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This provision expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant.

Your company wishes to seek approval of a combination of individually approved anti-hypertensive and anti-diabetic drugs. However, there is no Reference Listed Drug (RLD) for the proposed combination. Which of the following regulatory pathways is most applicable? A. 505(b)(2) B. 510(k) C. 505(b)(1) D. 505(j)

A. 505(b)(2) A 505(b)2 NDA relies at least in part on data that is not developed by the applicant. Reference listed drug means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application.

A key parameter for a pharmaceutical product has a specification range of 90-100. Which of the following postmarketing specification changes would require FDA notification prior to making the change? A. 89-100 B. 90-99 C. 95 +/- 5 D. 95-100

A. 89-100 Notification is required when the specification range is widened. VIII. SPECIFICATIONS —Major Changes (Prior Approval Supplement) The following are examples of changes in specifications considered to have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. Relaxing an acceptance criterion except as otherwise provided for in this guidance (e.g., section VIII.C.1.b, VIII.C.1.e). —Moderate Changes (Supplement - Changes Being Effected) —Supplement - Changes Being Effected in 30 Days b. Relaxing an acceptance criterion

At what point after a company submits an NDA will FDA provide the applicant with an opportunity to meet with agency reviewers to inform the company of the general progress and status of its application and to advise of deficiencies identified by that time and not already communicated? A. 90-day conference B. 30-day conference C. 60-day conference D. 120-day conference

A. 90-day conference Approximately 90 days after the agency receives the application, FDA will provide applicants with an opportunity to meet with agency reviewers. The purpose of the meeting will be to inform applicants of the general progress and status of their applications, and to advise applicants of deficiencies identified by that time and not already communicated. This meeting will be available on applications for all new chemical entities and major new indications of marketed drugs. Such meetings will be held at the applicant's option, and may be held by telephone if mutually agreed. Such meetings ordinarily would not be held on abbreviated applications because they are not submitted for new chemical entities or new indications.

A special control for a medical device may include: A. A black box warning included in the package insert of a new medical device B. Compliance with all current Good Manufacturing Practices C. Listing the device with FDA D. A PMA submission to FDA

A. A black box warning included in the package insert of a new medical device General controls include: 1. Establishment Registration of companies which are required to register under 21 CFR Part 807.20, such as manufacturers, distributors, repackagers and relabelers. 2. Medical Device Listing with FDA of devices to be marketed. 3. Manufacturing devices in accordance with Good Manufacturing Practices (GMP in 21 CFR Part 820. 4. Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809. 5. Submission of a premarket notification [510(k)] before marketing a device. Class II—Special Controls Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.

An orphan drug product means a product intended for use in a rare disease or condition as defined in FD&C Act Section 526. According to regulations, what constitutes a rare disease or condition? A. A disease or condition which affects fewer than 200,000 people in the US B. A disease or condition which affects fewer than 2% of the population in the US C. A disease or condition identified as rare by the American Medical Association D. A disease or condition for which the mode of action has not been determined

A. A disease or condition which affects fewer than 200,000 people in the US

Information that must be included in an IND includes which of the following? A. A list of all components used in the manufacture of the investigational drug product B. A statement of compliance with applicable GMPs C. Statistical methods to be used in the analysis of phase II and III clinical trials D. Results of accelerated stability studies on three lots of the investigational drug product

A. A list of all components used in the manufacture of the investigational drug product A. See 21 CFR 312.23(a)(7)(iv)(b). B. Not required under 21 CFR 312. C. See 21 CFR 312.23(a)(6)(iii). D. See 21 CFR 312.23(a)(7)(iv)(a) and (b).

A company has a 510(k) device and wants to expand its indications for use. The device can be used for the new indication, which includes a new and distinguishable patient population, with only minor changes made to the device's specifications. What are the actions that need to take place before marketing the device for the new indication? A. A new 510k needs to be submitted with an appropriate testing for the new indication B. Since the changes to the device specifications are minor, a special 510k can be submitted C. The device can be marketed right away and the change described in the Annual Report D. The device can be marketed after submission of labeling change

A. A new 510k needs to be submitted with an appropriate testing for the new indication A new indication for use requires a new 510(k) clearance.

Which of the following does NOT describe requirements for reserve samples? A. A reserve sample representative of one lot of shipped product per year must be retained B. The reserve sample should be at least twice the amount required for all tests required to determine whether the active ingredient meets established specifications C. Reserve samples should be stored under conditions in line with those on the product labeling D. Any evidence of reserve sample deterioration should be investigated and documented

A. A reserve sample representative of one lot of shipped product per year must be retained A reserve sample representative of each lot of each shipment of each active ingredient shall be retained—NOT one lot of shipped product per year.

Which of the following does NOT describe requirements for reserve samples? A. A reserve sample representative of one lot of shipped product per year must be retained B. The reserve sample should be at least twice the amount required for all tests required to determine whether the active ingredient meets established specifications C. Reserve samples should be stored under conditions in line with those on the product labeling D. Any evidence of reserve sample deterioration should be investigated and documented

A. A reserve sample representative of one lot of shipped product per year must be retained A reserve sample representative of each lot of each shipment of each active ingredient shall be retained—NOT one lot of shipped product per year.

A regulatory affairs professional is developing SOPs for a firm to cover compliance with drug GMPs. The firm's SOPs should require out-of-specification (OOS) test results to be completed within: A. A timely manner B. 15 days C. 30 days D. 45 days

A. A timely manner 21CFR 211.192 requires an investigation, but does not specify a time frame. October 2006 GMP guidance states that investigation of out-of-specification test results should be timely.

A marketing department plans to launch a series of educational speaker's programs for one of the company's drug/biologic products. Which of the following statements is a regulation that applies to promotional activities? A. AB. Special PMA Supplement—Changes Being Effecteddequate and well-controlled studies are required to substantiate all conclusions presented B. The company may suggest speakers or content for the presentations C. An independent third-party organization must manage the seminar series D. All speakers must disclose any financial relationships with the sponsoring company

A. Adequate and well-controlled studies are required to substantiate all conclusions presented A. This is interpreted as a promotional activity and subject to advertising regulations. There are also a variety of FDA guidance documents addressing these activities. 21 CFR 202.1(e)(6)(ii). B. These suggestions are provided by the FDA in guidance documents addressing Industry-Supported Scientific and Educational Activities, but are not found in the regulations. B.This type of information does not constitute documented scientific data. C. See explanation B. D. See explanation B.

Under the statutory violations, lack of an approved PMA for a PMA device that is not exempt and is in commercial distribution is considered to be: A. Adulteration B. Improper use C. Misbranded D. Fraudulent

A. Adulteration PMA products introduced into commercial distribution without an approval PMA are considered to be adulterated. FD&C Act 501(f).

What is a major CMC concern with biologics that is minor in most synthetic drugs? A. Allergenicity B. Toxicity C. Genotoxicity D. Carcinogenicity

A. Allergenicity

Which of the following statements regarding a Request For Designation (RFD) is FALSE? A. An RFD must be submitted to the Office of Combination Products (OCP) prior to review of any combination product. B. An RFD should be submitted when the jurisdiction of a combination or noncombination product is unclear or in dispute. C. The sponsor's recommendation as to which agency component should have primary jurisdiction must be included in the RFD. D. The sponsor may withdraw an RFD after submission and prior to issuance of jurisdictional determination by FDA.

A. An RFD must be submitted to the Office of Combination Products (OCP) prior to review of any combination product. This statement is FALSE because the RFD process is not mandatory. 21 CFR Part 3 covers the RFD process. Additionally, the FDA guidance document How to Write a Request for Designation (RFD) describes the process in detail.

The quality assurance manager of a small company with 12 employees is the company's only internal auditor and has been performing all internal quality system audits for three years. This does not meet the requirements for performing internal quality systems audits because: A. Auditor independence has not been ensured B. There is no one in the company qualified to train the quality assurance manager in quality auditing principles C. Quality system audits cannot be performed by the same auditor for more than two audits in a row D. The Audit Reports need to be approved by a second internal auditor not involved with the specific audit

A. Auditor independence has not been ensured Auditor independence has not been ensured because the quality assurance manager is auditing areas of the quality system for which he/she is responsible. This is not permitted.

Financial disclosure by investigators carrying out the clinical study is required during the period of the study and for one year following its completion if they have: A. Been a prior employee of the sponsor company and own stock worth more than $50,000 (US) B. Been paid $15,000 (US) for conducting clinical trials with the sponsor C. A spouse who had been paid as a consultant by the company before the study began D. Is not a requirement for Phase 2 studies

A. Been a prior employee of the sponsor company and own stock worth more than $50,000 (US) "Compensation affected by the outcome of clinical studies" means compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest. (b) "Significant equity interest in the sponsor of a covered study" means any ownership interest, stock options or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a non-publicly traded corporation), or any equity interest in a publicly traded corporation that exceeds $50,000 during the time the clinical investigator is carrying out the study and for one year following completion of the study.

Financial Disclosure is required for investigators who, during the time the clinical investigator is carrying out the study and for one year following the completion of the study, have: A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD B. Been paid $15,000 USD for conducting clinical trials with the sponsor C. A spouse who has been paid as a consultant by the company before the study began D. Is not a requirement for Phase 2 studies

A. Been a prior employee of the sponsor company and own stock worth more than $50,000 USD

When assembling an NDA, all of the following sections are required except for: A. Bioequivalence B. Chemistry Manufacturing and Controls C. Index D. Non-clinical Pharmacology and Toxicology

A. Bioequivalence A. Bioequivalence data is required in an ANDA, not an NDA (21 CFR 314.94 (7).) B. Required in an NDA. (21 CFR 314.50(d)(1).) C. Index, or Table of Contents, is required in an NDA. (21 CFR 314.50(b).) D. Non-clinical Pharmacology and Toxicology is required in an NDA. (21 CFR 314.50(d)(2).)

Which FDA center should have jurisdiction for the premarket review and regulation of a nasal spray single-entity combination product that uses a drug as its PMOA? A. CDRH B. DER C. CBER D. CDRH and CDER

A. CDRH

RUO and IUO products A. Cannot be marketed with diagnostic claims B. are subject to QSR requirements C. are considered safe and effective for IVD use

A. Cannot be marketed with diagnostic claims

How should an NDA holder report a change to filtration parameters for aseptic processing (including flow rate, pressure, time or volume, but not filter material or pore size rating). A. Changes Being Effected in 30-Days B. Changes Being Effected in 0-Days C. Prior Approval Supplement D. Annual Report

A. Changes Being Effected in 30-Days The holder of an approved application under section 505 of the act must assess the effects of the change before distributing a drug product made with a manufacturing change. Examples from Guidance for Industry: Changes to an Approved NDA or ANDA, 2004: The following are examples of changes considered to have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. Changes to filtration parameters for aseptic processing (including flow rate, pressure, time, or volume, but not filter materials or pore size rating) when additional validation studies for the new parameters should be performed.

To avoid the potential for cross-contamination, FDA requires the manufacture of penicillin products to be: A. In a building separated from other manufacturing buildings. B. In plants that are inspected quarterly. C. In a facility with a separated air handling system from those used for other drug products for human use. D. Under laminar flow protection that is validated periodically.

C. In a facility with a separated air handling system from those used for other drug products for human use. GMP requires dedicated facilities for penicillin manufacture with separate air handling system from other drug products used for human use. 21 CFR 211.42(d), 211.46(d).

How should an NDA holder report a change to filtration parameters for aseptic processing (including flow rate, pressure, time or volume, but not filter material or pore size rating). A. Changes Being Effected in 30-Days B. Changes Being Effected in 0-Days C. Prior Approval Supplement D. Annual Report

A. Changes Being Effected in 30-Days The holder of an approved application under section 505 of the act must assess the effects of the change before distributing a drug product made with a manufacturing change. Examples from Guidance for Industry: Changes to an Approved NDA or ANDA, 2004: The following are examples of changes considered to have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. Changes to filtration parameters for aseptic processing (including flow rate, pressure, time, or volume, but not filter materials or pore size rating) when additional validation studies for the new parameters should be performed.

Your company manufactures a combination internal analgesic product, regulated under a tentative final monograph. An Advisory Committee meeting is being planned to discuss potentially lowering the maximum daily dose of one of the internal analgesic active ingredients, or limiting the single dosage unit. This will impact your product, and you plan to provide safety and efficacy data to FDA to support the dosing regimen that currently exists for your product. How, as the regulatory professional, do you communicate with FDA regarding this topic? A. Citizens Petition B. Request a Type A meeting with FDA C. Request a Type B meeting with FDA D. Request a Type C meeting with FDA

A. Citizens Petition

Which of the following devices are not subject to requirements for Design Controls? A. Class I devices exempted by regulation. B. Class II devices that have been down classified from Class III. C. Class III devices. D. Devices automated with computer software.

A. Class I devices exempted by regulation. While most Class I devices are not subject to design controls, Class I devices listed in 820.30(a)(2) are required to be under design controls.

A company's competitor is marketing a Class II suture which dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. The company's new sutures can be marketed after which of the following occurs? A. Clearance of 510(k) B. Submission in a periodic report C. Clinical studies in an annual report D. Submission of labeling change

A. Clearance of 510(k) A. A new intended use requires a 510(k) clearance. B. Periodic reporting and annual reports do not apply to Class II devices. C. See explanation B. D. See explanation A.

In order to be approved by FDA, a generic drug must be therapeutically equivalent to the branded product with the exception of: A. Dosage Form B. Route of Administration C. Inactive Ingredient(s) D. Labeling

C. Inactive Ingredient(s) The law requires that generic drugs approved by FDA have the same active ingredient(s), dosage form, strength, route of administration, labeling, and conditions for use as the branded product, and that the generic and branded drug be bioequivalent. The inactive ingredients can be different. Sec. 314.92 Drug products for which abbreviated applications may be submitted. For determining the suitability of an abbreviated new drug application, the term "same as" means identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use, except that conditions of use for which approval cannot be granted because of exclusivity or an existing patent may be omitted.

An IRB-approved Informed Consent Form should contain all of the following EXCEPT: A. Description of the foreseeable risks of the study B. Disclosure about the alternative treatments available C. Information about the treatment groups to which the patient is assigned D. Explanation of conditions for any compensation offered

C. Information about the treatment groups to which the patient is assigned

During a QSIT audit of a medical device manufacturer, an FDA inspector requests the company's internal audit schedule. While reviewing the documents presented, the inspector discovers an internal audit results and summary report also has been provided, which identifies major quality system deficiencies. The inspector decides to check on the same areas of deficiency as the internal audit and determines the company has not adequately addressed the deficiencies. The inspector ends up issuing a 483. What could have been done by the company to avoid this 483? A. Clearly identify what the inspector was requesting and thoroughly review all documentation before presenting the documentation to the inspector B. The company could have taken the audit results and summary report away from the inspector before he or she completed the review of the documents C. Request the inspector to revise the 483 before he/she leaves because the information was not requested nor intended to be presented to the inspector D. There is no way to avoid a 483 in this situation because the inspector is privy to all internal audit results and reports

A. Clearly identify what the inspector was requesting and thoroughly review all documentation before presenting the documentation to the inspector An FDA inspector can request and receive the audit schedule information to establish the company has an internal audit program. However, a company is not obligated to provide internal audit report summaries. In this case, the internal audit summary was provided by the company in error, not at the request of the inspector. It is important for a company to provide only information that is requested by an inspector. The inspector can use any information provided to him or her to identify deficiencies in a company's Quality System, even if it was not requested. Sec. 820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a re-audit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and re-audit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented. Guidance: Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements.

During QSIT (Quality System Inspection Technique) audit of a medical device manufacturer, an FDA inspector requests the company's internal audit schedule. While reviewing the documents presented, the inspector discovers that an internal audit results and summary report has also been provided, which identifies major quality system deficiencies. The inspector decided to check on the same areas of deficiency as the internal audit and determines that the company has not adequately addressed the deficiencies. The inspector ends up issuing a 483. What could have been done by the company to avoid this 483? A. Clearly identify what the inspector was requesting and thoroughly review all documentation before presenting the documentation to the inspector. B. The company could have taken the audit results and summary report away form the inspector before he or she completed the review of the documents Request the inspector to revise the 483 before he.she leaves because the information was not requested nor intended to be presented to the inspector. D. There is no way to avoid a 483 in this situation because the inspector is privy to all internal audit results and reports

A. Clearly identify what the inspector was requesting and thoroughly review all documentation before presenting the documentation to the inspector.

A deficiency letter may be issued to a company during review of a Biologics License Application (BLA) for which of the following? A. Clinical testing did not include enough subjects B. The BLA was not submitted electronically C. The sponsor failed to have a meeting with FDA prior to submitting the BLA to discuss the product and clinical testing plan D. The submission did not include a Drug Master File (DMF) with information about facilities and processes used in manufacturing

A. Clinical testing did not include enough subjects A. FDA will not approve a BLA if it does not contain adequate clinical data (which may be affected by the number of sites where testing was B. although FDAMA originally required all submissions to be electronic by 2002, the implementation of this requirement has been delayed and the extent of electronic information to include in a BLA is still partially at the discretion of the company. C. only a recommendation and not a requirement to participate in a meeting with FDA prior to submission of a BLA. D. a DMF is optional in a BLA and pertinent information regarding facilities and processing can be incorporated directly into the BLA; a DMF can be used to submit information from a contract manufacturer without revealing confidential information to the applicant.

The final authority for ensuring the adequacy of an Investigational New Drug (IND) Informed Consent Form resides with the: A. IND sponsor B. FDA C. Institutional Review Board (IRB) D. Person conducting the informed consent process with the patient

C. Institutional Review Board (IRB) Consent Document Content For studies subject to the requirements of FDA regulations, the Informed Consent documents should meet the requirements of 21 CFR 50.20 and contain the information required by each of the eight basic elements of 21 CFR 50.25(a), and each of the six elements of 21 CFR 50.25(b) appropriate to the study. IRBs have the final authority for ensuring the adequacy of the information in the Informed Consent document. The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must review and approve: (i) The required information sheet; (ii) The adequacy of the plan to disseminate information, including distribution of the information sheet to potential recipients, on the investigational product (e.g., in forms other than written); (iii) The adequacy of the information and plans for its dissemination to health care providers, including potential side effects, contraindications, potential interactions, and other pertinent considerations; and (iv) An informed consent form as required by part 50 of this chapter, in those circumstances in which DOD determines that informed consent may be obtained from some or all personnel involved. 21 CFR 56.103 also says: a) Except as provided in 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part. Or more generically the reference could just be to 21 CFR 56, which outlines the roles and responsibilities of an IRB.

A deficiency letter may be issued to a company during review of a Biologics License Application (BLA) for which of the following? A. Clinical testing did not include enough subjects B. The BLA was not submitted electronically C. The sponsor failed to have a meeting with FDA prior to submitting the BLA to discuss the product and clinical testing plan D. The submission did not include a Drug Master File (DMF) with information about facilities and processes used in manufacturing

A. Clinical testing did not include enough subjects Response A is correct, as FDA will not approve a BLA if it does not contain adequate clinical data (which may be affected by the number of sites where testing was performed) to demonstrate safety and efficacy. Response B is incorrect; although FDAMA originally required all submissions to be electronic by 2002, the implementation of this requirement has been delayed and the extent of electronic information to include in a BLA is still partially at the discretion of the company. Response C is incorrect because it is only a recommendation and not a requirement to participate in a meeting with FDA prior to submission of a BLA. Response C is incorrect because a DMF is optional in a BLA and pertinent information regarding facilities and processing can be incorporated directly into the BLA; a DMF can be used to submit information from a contract manufacturer without revealing confidential information to the applicant.

CBER Biologics include the following categories except: A. Cytokines, growth factors B. Gene therapy C. Toxins intended for immunization D. Blood, blood components and related products

A. Cytokines, growth factors

Which of the following is true about DMFs? A. DMFs are not reviewed until referenced by a marketing application. B. DMFs do not require annual updates. C. The only types of DMFs recognized by FDA are Type I, Type II and Type III. D. A sponsor does not need written permission to reference a DMF.

A. DMFs are not reviewed until referenced by a marketing application. See 21 CFR 314.420(a) and the CDER guidance entitled Guidance for Drug Master Files published September 1989.

Which of the following is true about DMFs? A. DMFs are not reviewed until referenced by a marketing application. B. DMFs do not require annual updates. C. The only types of DMFs recognized by the FDA are Type I, Type II and Type III. D. A sponsor does not need written permission to reference a DMF.

A. DMFs are not reviewed until referenced by a marketing application. See 21 CFR 314.420(a) and the CDER guidance entitled "Guidance for Drug Master Files" published September 1989.

Which of the following is NOT an example of an annual reportable change for a marketed product? A. Deletion of a specification for drug substance B. A change in specification made to comply with an official compendium C. An editorial change to a label D. Tightening of acceptance criteria

A. Deletion of a specification for drug substance Deletion of a specification for drug substance requires a PAS. Sec. 314.70 Supplements and other changes to an approved application. (b) Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes) (1) A supplement must be submitted for any change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. (2) These changes include, but are not limited to: (i) Except those described in paragraphs (c) and (d) of this section, changes in the qualitative or quantitative formulation of the drug product, including inactive ingredients,or in the specifications provided in the approved application

Which of the following is NOT an example of an annual reportable change for a marketed product? A. Deletion of specification for drug substance B. A change in specification made to comply with an official compendium C. An editorial change to a label D. Tightening of acceptance criteria

A. Deletion of specification for drug substance

During a review of an internal audit, the auditor discovers a product being manufactured consisting of a battery-operated toothbrush impregnated with nonfluoridated toothpaste. There are no controls for the manufacture of the finished product. Compliance with which of the following is required for the manufacture of this product? A. Device QSR regulations B. Drug GMP regulations C. Cosmetic GMP regulations D. No controls required

A. Device QSR regulations A. The battery-operated toothbrush is a device and covered by GMPs. See 21 CFR 872.6865, 860.3(C)(1). B. Nonfluoridated toothpaste is not a drug. See 201(p) of the FD&C Act. C. There are no cosmetic GMP regulations. D. See explanation A.

According to Quality System Regulation, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record B. Device master record C. Premarket notification D. Investigational device exemption

A. Device history record

According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record B. Device master record C. Quality manual D. Design history file

A. Device history record This contains the dates of manufacture, the quantity manufactured, the quantity released for distribution, control numbers used and the acceptance records which demonstrate the device is manufactured in accordance with the DMR. See 21 CFR 820.184.

According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record. B. Device master record. C. Complaint files. D. Design history file.

A. Device history record. This contains the dates of manufacture, the quantity manufactured, the quantity released for distribution, control numbers used and the acceptance records which demonstrate the device is manufactured in accordance with the DMR. 21 CFR 820.184.

A company has been issued a Complete Response Letter by FDA. The company views many of the deficiencies as minor. The regulatory professional should meet with the team to: A. Devise a strategy for responding to all deficiencies identified by FDA B. Devise a strategy to respond to any minor deficiencies in order to restart the review clock C. Inform the team that a Class 1 resubmission has a six-month review clock D. Inform the team that a Class 2 resubmission has a three-month review clock

A. Devise a strategy for responding to all deficiencies identified by FDA Resubmissions purport to answer all of the deficiencies that need to be addressed by the applicant prior to approval of the original application as set forth in a previous action letter.

A company has been issued a Complete Response Letter by FDA. The company views many of the deficiencies as minor. The regulatory professional should meet with the team to: A. Devise a strategy for responding to all deficiencies identified by FDA B. Devise a strategy to respond to any minor deficiencies in order to restart the review clock C. Inform the team that a Class 1 resubmission has a six-month review clock D. Inform the team that a Class 2 resubmission has a three-month review clock

A. Devise a strategy for responding to all deficiencies identified by FDA Resubmissions purport to answer all of the deficiencies that need to be addressed by the applicant prior to approval of the original application as set forth in a previous action letter.

A company has been issued a Complete Response Letter by FDA. The company views many of the deficiencies as minor. The regulatory professional should meet with the team to: A. Devise a strategy for responding to all deficiencies identified by FDA B. Devise a strategy to respond to any minor deficiencies in order to restart the review clock C. Inform the team that a Class 1 resubmission has a six-month review clock D. Inform the team that a Class 2 resubmission has a three-month review clock

A. Devise a strategy for responding to all deficiencies identified by FDA Resubmissions purport to answer all of the deficiencies that need to be addressed by the applicant prior to approval of the original application as set forth in a previous action letter.

With respect to drug product distribution procedures, a distributor is required to do all of the following EXCEPT: A. Establish a system whereby the oldest approved stock of a drug is distributed last. B. Establish written procedures describing the distribution of drug products. C. Establish a system whereby the oldest approved stock of a drug is distributed first. D. Establish a system by which the distribution of each lot can readily be tracked and the lot recalled, if necessary.

A. Establish a system whereby the oldest approved stock of a drug is distributed last. According to §211.150, this is not required of a distributor since this way of rotating stock would potentially allow a drug product to expire in storage while awaiting distribution.

Failure to comply with GMPs is the statutory violation most often cited by FDA against device manufacturers. Which of the following is the most accurate source for this information? A. FDA Quarterly Report B. Medical Device and Diagnostic Industry C. RAPS Regulatory Affairs Focus D. F-D-C Reports

A. FDA Quarterly Report A. FDA Quarterly Report contains information on significant FDA activities and reports and analyzes all statutory violations. B. This is a commercial industry publication which contains limited accounts of this information. C. This is a publication of RAPS which may contain limited accounts of this information D.This is a commercial industry publication which contains limited accounts of this information.

Top management wants data about a competitor's device, drug and biologic recalls for the past 2 years. Which of the following is the most comprehensive resource for this data? A. FDA Web site B. Pink Sheet C. Gray Sheet D. FDA Consumer Magazine

A. FDA Web site A. Extensive data, including the FDA's Enforcement Report, is contained on the FDA home page. B. This contains only drug recalls. C. This contains only device recalls. D. The FDA Consumer Magazine only has partial information on recalls.

Recall status reports are usually provided to FDA every two to four weeks during the time period of a recall. Submission of these reports may cease when which of the following occurs? A. FDA terminates the recall B. Most of the affected products have been recovered C. All of the product consignees have been notified D. The problem which caused the recall has been corrected

A. FDA terminates the recall A. Only FDA can officially terminate a recall. 21 CFR 7.53. B. This is not acceptable. C. The affected product may still be unrecovered or unaccounted for. D. See explanation C.

Recall status reports are usually provided to FDA every two to four weeks during the time period of a recall. Submission of these reports may cease when which of the following occurs? A. FDA terminates the recall. B. Most of the affected products have been recovered. e. All of the product consignees have been notified. D. The problem which caused the recall has been corrected.

A. FDA terminates the recall. A. Only FDA can officially terminate a recall. 21 CFR 7.53 B. This is not acceptable. C. The affected product may still be unrecovered or unaccounted for. D. See explanation C.

A customer complains that he/she received your company's biological product but the primary label was not on the container. As the regulatory professional, what is the best course of action to take to address this incident? A. First, verify the complaint; second, investigate the manufacturing process; third, file a Biological Product Deviation report B. First, verify the complaint; second, investigate the manufacturing process; third, recall the entire lot C, First, verify the complaint; second, file the Biological Product Deviation report; third, issue the customer a credit/replace for the product D. First, verify the complaint; second, investigate the manufacturing process; third, issue a press release regarding the event

A. First, verify the complaint; second, investigate the manufacturing process; third, file a Biological Product Deviation report Depending on the type of biologic being manufactured, a recall may or may not be required. At minimum, one must verify the complaint, investigate the manufacturing process and file the Biological Product Deviation report.

An investigator wishes to begin clinical investigation using xenotrnasplation. He/she must submit the following: A. IND B. 505b2 C. BLA D. INAD

A. IND

Which regulatory body determines if a device is significant or non-significant risk? A. IRB B. CDRH C. Regulatory officer and CEO of the manufacturer D. CSO in charge of manufacturing

A. IRB

According to the drug regulations, which of the following approvals MUST be obtained before initiating a clinical study under an IND? A. IRB approval B. FDA approval C. patient approval D. medical monitor approval

A. IRB approval A The IRB responsible for the study site must review and approve the investigation prior to study initiation. 21 CFR 312.23 (a)(iv) B. INDs are not "approved" by FDA An IND must be submitted to FDA and "in effect" prior to initiating a clinical trial. 21 CFR 312.40 C. Patients do not "approve" clinical trials. D. The medical monitor follows the progress of the investigation after it is under way.

According to the drug regulations, which of the following approvals MUST be obtained before initiating a clinical study under an IND? A. IRB approval B. FDA approval C. Patient approval D. Medical monitor approval

A. IRB approval A. The IRB responsible for the study site must review and approve the investigation prior to study initiation. 21 CFR 312.23 (a)(iv). B. INDs are not "approved" by FDA. An IND must be submitted to FDA and "in effect" prior to initiating a clinical trial. 21 CFR 312.40. C. Patients do not "approve" clinical trials. D. The medical monitor follows the progress of the investigation after it is under way.

A serious adverse event of Grade 4, life-threatening hallucinations is reported by an investigator for an investigational drug in a Phase 3 clinical trial for patients with advanced stage malignant melanoma. Grade 1-3 (mild, moderate, severe) hallucinations have been reported previously in the Investigator's Brochure. Youadvise the medical monitor to confirm that the severity grade for this AE is correctly reported by the investigator. What subsequent reporting should follow? A. If AE is confirmed to be Grade 4, report as a serious and unexpected AE associated with the investigational drug to FDA via phone or facsimile within 7 calendar days, followed by a written report within 8 additional calendar days B. If AE is clarified as Grade 3 not Grade 4, report as a serious and unexpected adverse event to FDA in writing within 15 calendar days C. Regardless of AE severity grade, report as a serious and unexpected AE associated with the investigational drug to FDA in writing within 15 calendar days D. If AE is clarified to be Grade 3 not Grade 4, report as a serious adverse event in the IND annual safety report

A. If AE is confirmed to be Grade 4, report as a serious and unexpected AE associated with the investigational drug to FDA via phone or facsimile within 7 calendar days, followed by a written report within 8 additional calendar days Reporting criteria for drug AEs is serious AND unexpected, whereas the reporting criteria for device is only serious.

A medical device may be exported under Section 801(e) of the FD&C Act and shall not be deemed to be adulterated or misbranded under the act if all of the following apply for the device EXCEPT: A. It is in accordance with the specifications of the foreign purchaser B. It is not in conflict with the laws of the country to which it is intended for export C. It is 510(k) cleared or PMA approved D. It is labeled on the outside of the shipping package that it is "intended for export only"

C. It is 510(k) cleared or PMA approved A medical device that would not meet the requirements of the FD&C Act to be sold domestically (i.e. no 510(k) or PMA), may be exported under Section 801(e)(1) of the FD&C Act provided the device is intended solely for export and the device is: —in accordance with the specifications of the foreign purchaser; —not in conflict with the laws of the country to which it is intended for export; —labeled on the outside of the shipping package that it is intended for export; and —not sold or offered for sale in domestic commerce.

A serious adverse event of Grade 4, life-threatening hallucinations is reported by an investigator for an investigational drug in a Phase 3 clinical trial for patients with advanced stage malignant melanoma. Grade 1-3 (mild, moderate, severe) hallucinations have been reported previously in the Investigator's Brochure. You advise the medical monitor to confirm that the severity grade for this AE is correctly reported by the investigator. What subsequent reporting should follow? A. If AE is confirmed to be Grade 4, report as a serious and unexpected AE associated with the investigational drug to FDA via phone or facsimile within 7 calendar days, followed by a written report within 8 additional calendar days B. If AE is clarified as Grade 3 not Grade 4, report as a serious and unexpected adverse event to FDA in writing within 15 calendar days C. Regardless of AE severity grade, report as a serious and unexpected AE associated with the investigational drug to FDA in writing within 15 calendar days D. If AE is clarified to be Grade 3 not Grade 4, report as a serious adverse event in the IND annual safety report

A. If AE is confirmed to be Grade 4, report as a serious and unexpected AE associated with the investigational drug to FDA via phone or facsimile within 7 calendar days, followed by a written report within 8 additional calendar days Reporting criteria for drug AEs is serious AND unexpected, whereas the reporting criteria for device is only serious.

A serious adverse event of Grade 4, life-threatening hallucinations is reported by an investigator for an investigational drug in a Phase 3 clinical trial for patients with advanced stage malignant melanoma. Grade 1-3 (mild, moderate, severe) hallucinations have been reported previously in the Investigator's Brochure. You advise the medical monitor to confirm that the severity grade for this AE is correctly reported by the investigator. What subsequent reporting should follow? A. If AE is confirmed to be Grade 4, report as a serious and unexpected AE associated with the investigational drug to FDA via phone or facsimile within 7 calendar days, followed by a written report within 8 additional calendar days B. If AE is clarified as Grade 3 not Grade 4, report as a serious and unexpected adverse event to FDA in writing within 15 calendar days C. Regardless of AE severity grade, report as a serious and unexpected AE associated with the investigational drug to FDA in writing within 15 calendar days D. If AE is clarified to be Grade 3 not Grade 4, report as a serious adverse event in the IND annual safety report

A. If AE is confirmed to be Grade 4, report as a serious and unexpected AE associated with the investigational drug to FDA via phone or facsimile within 7 calendar days, followed by a written report within 8 additional calendar days Reporting criteria for drug AEs is serious AND unexpected, whereas the reporting criteria for device is only serious.

Which of the following statements is true about electronic submissions? A. If you file an eCTD, all subsequent amendments to the marketing application must be electronic. B. FDA does not have a preferred format/file structure for e-submissions. C. Only NDAs may be submitted electronically. D. All FDA divisions accept electronic submissions.

A. If you file an eCTD, all subsequent amendments to the marketing application must be electronic. According to Section E of the Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications, first published in October 2005 and revised in April 2006, "Once you begin to submit a specific application in electronic format based on this guidance, subsequent submissions to the application, including amendments and supplements, should include eCTD backbone files."

Which is true about electronic submissions? A. If you file an eCTD, all subsequent amendments to the marketing application must be electronic. B. The FDA does not have a preferred format/file structure for e-submissions. C. Only NDAs may be submitted electronically. D. All FDA divisions accept electronic submissions.

A. If you file an eCTD, all subsequent amendments to the marketing application must be electronic. According to the guidance "Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications", first published in October 2005 and revised in April 2006, Section E, "Once you begin to submit a specific application in electronic format based on this guidance, subsequent submissions to the application, including amendments and supplements, should include eCTD backbone files."

FDA will generally grant a waiver of in vivo bioequivalence testing for which of the following generic drug products? A. Intravenous injections B. Antibiotic suspensions C. Intramuscular injection D. Uncoated tablets

A. Intravenous injections A. The in-vivo bioequivalence of an approved drug, administered intravenously, is self-evident and does not need to be tested. 21 CFR 320.22(b)(1). B. Orally administered products may vary in bioequivalence and, therefore, it is not self-evident. C. Intramuscularly administered products may vary in bioequivalence and, therefore it is not self-evident. D. See explanation B.

On Monday, commercial stability batch testing for an approved drug produced results outside the specification. No assignable cause had been identified as of Wednesday. What is the best action for the regulatory professional to take? A. Issue a Field Alert B. Initiate retesting C Initiate resampling D. Issue an Investigative Protocol

A. Issue a Field Alert Issuance of a Field Alert has a 72-hour (three working day) time limit from the time of confirmed OOS. Note the product must be commercially available for human use. Sec. 314.81 Other postmarketing reports. (b) Reporting requirements. The applicant shall submit to the Food and Drug Administration at the specified times two copies of the following reports: (1) NDA--Field alert report. The applicant shall submit information of the following kinds about distributed drug products and articles to the FDA district office that is responsible for the facility involved within three working days of receipt by the applicant. The information may be provided by telephone or other rapid communication means, with prompt written follow up. The report and its mailing cover should be plainly marked: "NDA--Field Alert Report." (i) Information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article. (ii) Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application.

Which one of the following should NOT be present in a typical meeting with the FDA? A. Lawyer B. Regulatory Affairs representative C. Medical Officer D. Pharmacologist

A. Lawyer

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A. Manually generated, time-stamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records B. Validation of systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records C. Authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record or perform the operation at hand D. Establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification

A. Manually generated, time-stamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records Time-stamped audit trails must be secure, computer-generated records that independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Manually generated records are NOT acceptable.

Which federal law made it illegal for physicians being reimbursed by federally funded programs to prescribe or recommend that the patient use a particular manufacturer's medical products when the doctor receives payment from that manufacturer? A. Medicare and Medicaid Patient Protection Act of 1987 B. Food, Drug, and Cosmetic Act of 1938 (FD&C Act) C. Food and Drug Administration Modernization Act of 1997 (FDAMA) D. Food and Drug Administration Amendments Act of 2007 (FDAAA)

A. Medicare and Medicaid Patient Protection Act of 1987 The Medicare and Medicaid Patient Protection Act of 1987 is also known as the Federal Anti-Kickback Statute and makes it illegal for any person—e.g., healthcare provider, office manager or sales agent—to knowingly and willingly solicit, offer, pay or receive "remuneration" (including kickbacks, bribes, rebates or anything of value) directly or indirectly in cash or in kind to any person to induce or cause that person to prescribe a product for which payment may be made in whole or in part under a federal or federally funded healthcare plan.

Which module of CTD, which is not officially considered to be a module, is country specific? A. Module 1 B. Module 2 C. Module 3 D. Module 4

A. Module 1

Which module of CTD deals with clinical study reports? A. Module 5 B. Module 2 C. Module 3 D. Module 4

A. Module 5

Distribution records for drug products must reference or contain: A. Name and address of the consignee B. IND Annual Report date C. IND information amendment date D. Route of administration

A. Name and address of the consignee Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.

A medical device company allows its sales force to maintain a product inventory in the field. The device has an expiration date indicated on its labeling. A sales person notes that one of his products has expired and contacts the headquarters office for direction. He is told to return the product to the headquarter office for replacement. The return of this product is considered as what type of recall? A. Not a recall-it is considered normal stock rotation B. Class I recall C. Class II recall D. Class III recall

A. Not a recall-it is considered normal stock rotation This action will be considered as market withdrawal; involves no violation of the act. It is considered normal stock rotation. Regulatory Reference: 21 CFR 806

Your company recently gained approval for a novel biologic drug to treat a rare disease that has no other known therapy. The demand for your compound is several times what was anticipated and you are running into a supply issue due to the scarcity of a manufacturing component. Which manufacturing license strategy would immediately help to address the supply shortage? A. Obtain the initial and partially-manufactured version of the product from unlicensed facilities B. No immediate action is necessary until you expand your own manufacturing capabilities next year C. Share manufacturing between several manufacturers that are registered and licensed for specific aspects of the products manufacturing process D. Utilize a contract manufacturer where your company will hold the license and the contract facility will be under your control

A. Obtain the initial and partially-manufactured version of the product from unlicensed facilities -Answer A is correct because, in certain circumstances, you can work with unlicensed manufacturers to address a shortage. -Answer B is a distracter. -Answer C describes a situation where "shared manufacturing" is taking place. License applications/supplements must be filed concurrently and this process would not be considered an "immediate action." -Answer D is incorrect because contract manufacturing would not be considered the best option for "immediate action."

Your company recently gained approval for a novel biologic drug to treat a rare disease that has no other known therapy. The demand for your compound is several times what was anticipated and you are running into a supply issue due to the scarcity of a manufacturing component. Which manufacturing license strategy would immediately help to address the supply shortage? A. Obtain the initial and partially-manufactured version of the product from unlicensed facilities B. No immediate action is necessary until you expand your own manufacturing capabilities next year C. Share manufacturing between several manufacturers that are registered and licensed for specific aspects of the products manufacturing process D. Utilize a contract manufacturer where your company will hold the license and the contract facility will be under your control

A. Obtain the initial and partially-manufactured version of the product from unlicensed facilities A. is correct because, in certain circumstances, you can work with unlicensed manufacturers to address a shortage. B. is a distracter. C. describes a situation where "shared manufacturing" is taking place. License applications/supplements must be filed concurrently and this process would not be considered an "immediate action." D. is incorrect because contract manufacturing would not be considered the best option for "immediate action."

A drug manufacturer is assembling a clinical evaluation plan for a New Chemical Entity (NCE) to include in an IND submission. Which of the following NCE studies DOES NOT need to be included by the manufacturer in the clinical trial registry at www.clinicaltrials.gov? A. Phase 1 studies B. Phase 2 studies C. Phase 3 studies D. Phase 4 postmarketing studies

A. Phase 1 studies Clinical Trials That Must be Registered at ClinicalTrials.gov—FDAAA, Title VIII, Sec. 801 ("Applicable Clinical Trials") —Trials of drugs and biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation —Trials of devices: (a) a prospective clinical study of health outcomes comparing an intervention with a device, subject to FDA regulation, against a control in human subjects, (other than small feasibility studies), and (b) pediatric postmarket surveillance

An NDA holder wants to extend the drug product shelf life from two to three years. What is the best course of action to pursue? A. Present three years of real-time stability data on three consecutive batches following an approved stability protocol in the NDA Annual Report B. Present 18 months of accelerated stability data on three consecutive batches in the NDA Annual Report C. Present three years of real-time stability data on three consecutive batches in an NDA Changes Being Effected in 30-Days supplement D. Present 18 months of accelerated stability data on three consecutive batches in a NDA Changes Being Effected in 0-Days supplement

A. Present three years of real-time stability data on three consecutive batches following an approved stability protocol in the NDA Annual Report Data from stability studies should be provided on at least three consecutive batches of the drug product. An extension of an expiration dating period based on full shelf life data on production batches obtained under a protocol approved in the application

An NDA holder wants to extend the drug product shelf life from two to three years. What is the best course of action to pursue? A. Present three years of real-time stability data on three consecutive batches following an approved stability protocol in the NDA Annual Report B. Present 18 months of accelerated stability data on three consecutive batches in the NDA Annual Report C. Present three years of real-time stability data on three consecutive batches in an NDA Changes Being Effected in 30-Days supplement D. Present 18 months of accelerated stability data on three consecutive batches in a NDA Changes Being Effected in 0-Days supplement

A. Present three years of real-time stability data on three consecutive batches following an approved stability protocol in the NDA Annual Report Data from stability studies should be provided on at least three consecutive batches of the drug product. An extension of an expiration dating period based on full shelf life data on production batches obtained under a protocol approved in the application

When used in promotion, the established name of a prescription drug product should be: A. Printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined B. Printed in letters that are smaller than the proprietary name C. Printed in any size that can be clearly read D . Printed in a different color or distinct from the proprietary name

A. Printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined

When used in promotion, the established name of a prescription drug product should be: A. Printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined. B. Printed in letters that are smaller than the letters comprising the proprietary name or designation with which it is joined. C. Printed in any size that can be clearly read by users. D. Printed in a different color or distinct font as compared to the proprietary name or designation.

A. Printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined. The generic or established name must be at least half as large as the proprietary name letters.

What method of FDA notification would be required for a postapproval change described as "a change in technical grade" of a release-controlling excipient? A. Prior Approval Supplement B. Changes Being Effected 30-days Supplement C. Changes Being Effected 0-days Supplement D. Annual Report

A. Prior Approval Supplement The MR (modified-release) SUPAC guidance applies since the product is inferred to have a non-immediate release component. This type of change is classified as a Level 2 change (one that could have a significant effect on the product's formulation quality and performance). Thus, this change should be described in a Prior Approval Supplement and contain a minimum of three month's accelerated stability data and multipoint dissolution studies (or IVIV correlation), with long-term stability data of first production batch to follow in the Annual Report. Certain products (i.e., those with a narrow therapeutic range) could require bioequivalence documentation and/or stability data on three batches instead of one in the PAS.

Labeling for biologics must include? A. Product name, address and license number of the manufacturer, expiration date B. Product name, lot number, address of manufacturer C. Product name, expiration date, distributor name and address D. Product name, cell line (if applicable), package date

A. Product name, address and license number of the manufacturer, expiration date

Under IND/IDE regulations, obligations of a clinical study investigator do NOT include: A. Providing a final study report to the IRB B. Protecting the rights, safety and welfare of study subjects C. Controlling the drug under investigation D. Returning unused supplies of the drug to the sponsor

A. Providing a final study report to the IRB Clinical investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial. There is also an FDA draft guidance Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigator, issued May 2007. 21 CFR 312.64 - The investigator is not obligated to submit reports to the IRB. Investigators are responsible for submitting reports to the sponsor (i.e. - progress reports, safety reports, a final report).

A company has received a 10-page FDA-483. The regulatory affairs practitioner's supervisor has prepared a detailed response assuring FDA district office that corrective action has been taken for each observation. Which of the following should be done? A. Re-audit the company's corrective actions before the letter is sent B. Re-audit the company's corrective actions within three months, because FDA usually conducts reinspections within six months C. Re-audit the company's corrective actions during the next scheduled audit D. Re-audit the company's corrective actions immediately after the letter is sent

A. Re-audit the company's corrective actions before the letter is sent A. The letter from the supervisor states the corrective actions have already taken place. The firm may be subject to inspection at any time; therefore, these corrections should be reviewed. Title 18 of the US Code makes submitting false information to the government a criminal offense. B. To ensure corrections are in place prior to an official statement by the firm, an audit should not be delayed until after issuance of the letter to the FDA. C. See explanation B. D. See explanation B.

A drug manufacturer creates a game-based simulation to assist diabetes patients with management of their blood glucose levels and to motivate them to adhere to their medication schedules. The game will be based on a password protected website that will be made available to patients when an FDA-approved drug is prescribed to them. How will the game most likely be regulated by FDA? A. It should be included as part of the NDA submission B. It will be regulated as a Class I medical device B. It will be regulated as an in vitro diagnostic product C. It will not be an FDA regulated product

C. It will not be an FDA regulated product This type of "advertising" would fall under the category of a "help-seeking" advertisement because the product is not named, although it likely makes recommendations about actions that might be taken based on a particular symptom, i.e., low or elevated glucose levels. Unlike drug and device promotional labeling and prescription drug and restricted device advertising, disease awareness communications are not subject to the requirements of the FD&C Act and FDA regulations.

According to the Quality System Regulation, suitable maintenance of equipment is necessary to ensure that manufacturing specifications are met. All of the following are requirements for the equipment EXCEPT: A. A written maintenance schedule is required B. Allowable tolerances are posted on or near the equipment C. Maintenance must be performed at least annually D. Inspections of equipment must be documented

C. Maintenance must be performed at least annually QSR does not specify "annually": Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.

FDA may refuse to file a PMA for all of the following reasons EXCEPT: A. The application does not contain all the information required under Section 515(c)(1)(A)-(G) of the FD&C Act B. The PMA contains a false statement of material fact C. Major or minor deficiencies are identified with the clinical data after substantive review by FDA D. The PMA is not accompanied by a statement of either certification or disclosure as required by 21 CFR 54 Financial Disclosure by Clinical Investigators

C. Major or minor deficiencies are identified with the clinical data after substantive review by FDA Substantive review of the PMA submission will begin once FDA determines the submission will not be refused.

A blood center has discovered a unit of packed red blood cells previously shipped to a local hospital was stored inappropriately for four days during the manufacturing process. The blood center should: A. Recall the blood product and initiate a blood product deviation report to CBER within 45 calendar days of discovery of the deviation. B. Recall the blood product and initiate a blood product deviation report to CDRH within 45 calendar days of discovery of the deviation. C. Recall the blood product and initiate a blood product deviation report to CBER within 15 calendar days of discovery of the deviation. D. Recall the blood product and initiate a blood product deviation report to CDRH within 15 calendar days of discovery of the deviation.

A. Recall the blood product and initiate a blood product deviation report to CBER within 45 calendar days of discovery of the deviation. The appropriate FDA branch handling biologic products is CBER and the appropriate reporting period is 45 days from discovery of the manufacturing deviation. Under 21 CFR 606.171, a manufacturer is required to report certain events associated with the manufacturing, to include testing, processing, packing, labeling or storage, or with the holding or distribution of blood or a blood component, which may affect the safety, purity or potency of a distributed product. Safety, purity and potency are defined in 21 CFR 600.3(p), (r) and (s). Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible, but is required to submit reports at a date not to exceed 45 calendar days from the date of discovery of information reasonably suggesting a reportable event has occurred.

FDA may refuse to file a PMA for all of the following reasons EXCEPT: A. The application does not contain all the information required under Section 515(c)(1)(A)-(G) of the FD&C Act B. The PMA contains a false statement of material fact C. Major or minor deficiencies are identified with the clinical data after substantive review by FDA D. The PMA is not accompanied by a statement of either certification or disclosure as required by 21 CFR 54 Financial Disclosure by Clinical Investigators

C. Major or minor deficiencies are identified with the clinical data after substantive review by FDA Substantive review of the PMA submission will begin once FDA determines the submission will not be refused.

In a medical device company, which of the following units has ultimate responsibility for the integrity of the data and the quality of the product: A.Quality Assurance B. Quality Control C. Management D. Regulatory Compliance

C. Management Management has the ultimate responsibility to ensure the quality systems are effective and a quality policy is implemented and followed as intended, which assures the integrity of the data and quality of the product.

A blood center has discovered a unit of packed red blood cells previously shipped to a local hospital was stored inappropriately for four days during the manufacturing process. The blood center should: A. Recall the blood product and initiate a blood product deviation report to CBER within 45 calendar days of discovery of the deviation. B. Recall the blood product and initiate a blood product deviation report to CDRH within 45 calendar days of discovery of the deviation. C. Recall the blood product and initiate a blood product deviation report to CBER within 15 calendar days of discovery of the deviation. D. Recall the blood product and initiate a blood product deviation report to CDRH within 15 calendar days of discovery of the deviation.

A. Recall the blood product and initiate a blood product deviation report to CBER within 45 calendar days of discovery of the deviation. The appropriate FDA branch handling biologic products is CBER and the appropriate reporting period is 45 days from discovery of the manufacturing deviation. Under 21 CFR 606.171, a manufacturer is required to report certain events associated with the manufacturing, to include testing, processing, packing, labeling or storage, or with the holding or distribution of blood or a blood component, which may affect the safety, purity or potency of a distributed product. Safety, purity and potency are defined in 21 CFR 600.3(p), (r) and (s). Under 21 CFR 606.171(c), a manufacturer should submit reports as soon as possible, but is required to submit reports at a date not to exceed 45 calendar days from the date of discovery of information reasonably suggesting a reportable event has occurred.

The initial importer of a medical device must: A. Register and submit device list to FDA B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. None of the above

A. Register and submit device list to FDA

The initial importer of a medical device MUST: A. Register and submit device list to FDA. B. Maintain quality assurance files. C. Share responsibility for submittals with other distributors. D. Report device malfunctions in an annual report.

A. Register and submit device list to FDA.

The initial importer of a medical device MUST: A. Register and submit device list to FDA. B. Maintain quality assurance files. C. Share responsibility for submittals with other distributors. D. Report device malfunctions in an annual report.

A. Register and submit device list to FDA. A. Distributors must list all initially imported devices with the FDA and establish themselves as device importers. 21 CFR 807.20(c).

The initial importer of a medical device MUST: A. Register and submit device list to FDA. B. Maintain quality assurance files. C. Share responsibility for submittals with other distributors. D. Report device malfunctions in an annual report.

A. Register and submit device list to FDA. Distributors must list all initially imported devices with the FDA and establish themselves as device importers. 21 CFR 807.20(c).

A company acquired a new packaging facility located in the US to package its pharmaceutical drug products. What must be done for the start up of packaging operations at this facility? A. Register the establishment with FDA within five days after beginning the operation B. Contact Dun & Bradstreet to obtain a DUNs number C. Submit supplement to FDA D. Update listing information

A. Register the establishment with FDA within five days after beginning the operation Requirements for drug establishment registration and drug listing are set forth in Section 510 of the FD&C Act and Section 351 of the PHS Act, and 21 CFR Part 207. The owner or operator of an establishment entering into the manufacture, preparation, propagation, compounding or processing (which includes, among other things, repackaging and relabeling) of a drug or drugs and not exempt under section 510(g) of the FD&C Act or subpart B of 21 CFR part 207, must register the establishment with FDA within five days after beginning the operation (21 CFR 207.21(a) and 21 CFR 207.3(a)(8)).

A company acquired a new packaging facility located in the US to package its pharmaceutical drug products. What must be done for the start up of packaging operations at this facility? A. Register the establishment with FDA within five days after beginning the operation B. Contact Dun & Bradstreet to obtain a DUNs number C. Submit supplement to FDA D. Update listing information

A. Register the establishment with FDA within five days after beginning the operation Requirements for drug establishment registration and drug listing are set forth in Section 510 of the FD&C Act and Section 351 of the PHS Act, and 21 CFR Part 207. The owner or operator of an establishment entering into the manufacture, preparation, propagation, compounding or processing (which includes, among other things, repackaging and relabeling) of a drug or drugs and not exempt under section 510(g) of the FD&C Act or subpart B of 21 CFR part 207, must register the establishment with FDA within five days after beginning the operation (21 CFR 207.21(a) and 21 CFR 207.3(a)(8)).

The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report

A. Report incidents in which a device may have caused or contributed to a death or serious injury Initial importers are subject to Medical Device Reporting (MDR) under 21 CFR 803.40.

Your company recently had a successful End-of-Phase 2 meeting for a novel drug and would like your regulatory advice on the design for the pivotal Phase 3 study. The clinical compound team wants to use a primary endpoint and unusual design that has never been utilized in the therapeutic area you are studying. Which type of meeting would be the best choice for getting FDA alignment with your pivotal Phase 3 study? A. Request a Special Protocol Assessment Meeting B. Request a Pre-NDA Meeting C. Request a Type C Meeting D. Request a Type A Meeting

A. Request a Special Protocol Assessment Meeting Based on guidance documents, FDA encouraged the use of the SPA process for trials in which the proposed study design or endpoints are unusual, or for studies that involve an indication or disease for which the FDA has not previously approved a drug or biologic product. Pre-NDA is later, after you would need to discuss the Phase 3 trial design. A Type C Meeting would be better used for general drug development questions. Type A meetings generally are used for dispute resolution; they also are used if a sponsor wants a meeting after receiving comments from FDA on the SPA.

FDA is authorized to regulate advertising for what type(s) of medical devices? A. Restricted Devices B. Non-Restricted Devices C. All medical devices D. None, as this is the responsibility of the FTC

A. Restricted Devices "Under the FD&C Act, FDA has regulatory authority over the labeling of all medical devices. However, FDA's regulation of medical device advertising is limited to a subset of medical devices. The Federal Trade Commission (FTC) regulates the advertising, as opposed to the labeling, of most medical devices under sections 12-15 of the Federal Trade Commission Act, which prohibit false or misleading advertising of certain products that FDA regulates. (Title 15, United States Code [U.S.C.] section 52-55). Sections 502(q) and 502(r) of the FD&C Act authorize FDA to regulate the advertising of certain devices, which are known as restricted devices (discussed below). Section 502(r) also states that restricted devices are not subject to sections 12-15 of the Federal Trade Commission Act. Thus, FDA regulates the advertising of restricted medical devices while the FTC regulates the advertising of non-restricted devices."

A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510(k) C. Traditional 510(k) D. De novo 510(k)

A. Special 510(k) A Special 510(k) is allowed if a modification to the legally marketed device is being made that relies on compliance with design controls, including design validation. The incentive provided for manufacturers to choose this option is that ODE intends to process special 510(k)s within 30 days of receipt. See the CDRH guidance published in 1998 entitled The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.

All of the following would require a Type B Meeting request EXCEPT: A. Special Protocol Assessment (SPA) B. Pre-IND C. End-of-Phase 2 D. Pre-BLA

A. Special Protocol Assessment (SPA) Type A meetings generally will be reserved for dispute resolution meetings, meetings to discuss clinical holds and Special Protocol Assessment meetings requested by sponsors after FDA's evaluation of protocols (e.g., animal carcinogenicity protocols, final product stability protocols and clinical protocols for Phase 3 trials) in assessment letters. Type B meetings are (1) pre-IND meetings (21 CFR 312.82) (2) certain end of Phase 1 meetings (21 CFR 312.82) (3) end of Phase 2/pre-Phase 3 meetings (21 CFR 312.47) and (4) pre-NDA/BLA meetings (21 CFR 312.47).

A key component of a new device for which a PMA is being prepared is manufactured by a second company. Without revealing proprietary information to the finished product manufacturer, how can the component manufacturer make critical information available to FDA for review? A. Submit a Device Master File (MAF) B. File its own PMA C. Supply the applicable sections of the finished device manufacturer's PMA directly to FDA D. Include a certification in the finished device manufacturer's PMA that the proprietary information meets FDA's requirements

A. Submit a Device Master File (MAF) - A pre-market approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other information that the applicant has developed and regards as trade secret or confidential commercial financial information. - Often the applicant needs to use another party's product (e.g., ingredient, subassembly, or accessory) or facility in the manufacture of the device. In order that a sound scientific evaluation may be made of the PMA, IDE, or other device submission, the review of data and other information related to the other party's product, facility, or manufacturing procedures is required. - The other party, while willing to allow FDA's confidential review of this information, may not want the IDE, premarket notification [510(k)], or PMA applicant to have direct access to the information. - To help preserve the trade secrets of the ancillary medical device industry and at the same time facilitate the sound scientific evaluation of medical devices, FDA established the device master file system. - In addition, a master file may be considered when several applications may be submitted for different products which may use a common material or process, etc., such as the same sterilization method. This guideline only applies to the master files (MAFs) submitted to the Center for Devices and Radiological Health (CDRH). Master files in support of other products regulated by FDA, even though they may contain information previously submitted in an MAF, are to be submitted to the appropriate FDA center(s). The content and the way the master file is used may vary among FDA centers. Other master files submitted for review in support of documents filed with FDA are: - Biologics Master Files supporting Notices of Claimed Investigational Exemption for a New Drug (INDs) for biologics and biologic licenses. - Drug Master Files (DMFs) supporting Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs). - Food Master Files (FMFs) supporting Food Additive and Color Additive Petitions. - Veterinary Medicine Master Files supporting Investigational New Animal Exemptions (INADs) and New Animal Drug Applications (NADAs).

Sponsors of a clinical trial must immediately notify FDA and investigators of SAEs EXCEPT? A. Temporally associated with the use of the investigational item but are not serious and/or unexpected B. Described in the IB but with greater severity C. Life-threatening or result in inpatient hospitalization D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the drug

A. Temporally associated with the use of the investigational item but are not serious and/or unexpected

Sponsors of a clinical trial must immediately notify FDA and investigators of serious adverse events EXCEPT: A. Temporally associated with the use of the investigational item but are not serious and/or unexpected B. Described in the Investigator's Brochure but with greater severity C.Life-threatening or result in inpatient hospitalization D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the drug

A. Temporally associated with the use of the investigational item but are not serious and/or unexpected Events that are not undesirable are not adverse events. Events in animals are not reportable. Events of greater severity than described in the Investigator's Brochure are unexpected and therefore reportable.

Sponsors of a clinical trial must immediately notify FDA and investigators of serious adverse events EXCEPT: A. Temporally associated with the use of the investigational item but are not serious and/or unexpected B. Described in the Investigator's Brochure but with greater severity C. Life-threatening or result in inpatient hospitalization D. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the drug

A. Temporally associated with the use of the investigational item but are not serious and/or unexpected Events that are not undesirable are not adverse events. Events in animals are not reportable. Events of greater severity than described in the Investigator's Brochure are unexpected and therefore reportable. According to 21 CFR 312.32: Answer B should be reported 2)Unexpected fatal or life-threatening suspected adverse reaction reports . The sponsor must also notify FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than 7 calendar days after the sponsor's initial receipt of the information. Additionally, according to the Guidance Adverse Event Reporting to IRBs—Improving Human Subject Protection: An AE that is described or addressed in the investigator's brochure, protocol or Informed Consent documents, but occurs at a specificity or severity that is inconsistent with prior observations should be reported. According to 21 CFR 312.32 Answer ID 3 Should be reported: Increased rate of occurrence of serious suspected adverse reactions . The sponsor must report any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. According to 21 CFR 312.32 Answer ID 4 also should be reported: iii) Findings from animal or in vitro testing. The sponsor must report any findings from animal or in vitro testing, whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug, such as reports of mutagenicity, teratogenicity, or carcinogenicity, or reports of significant organ toxicity at or near the expected human exposure.

Which one of the following statements is NOT true with respect to both Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) for significant-risk devices? A. The investigational product must be manufactured in full compliance with cGMP B. Clinical studies must be approved by an Institutional Review Board C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise D. The application must include an environmental impact statement that contains a claim for categorical exclusion or an environmental assessment

A. The investigational product must be manufactured in full compliance with cGMP A. Devices under approved IDEs are exempt from cGMP regulations except for design control requirements; investigational new drugs must be compliant with cGMP for finished pharmaceuticals (21 CFR 211). B. See 21 CFR 312.66 and 21 CFR 812.42. C. See 21 CFR 312.40(b)(1) and 21 CFR 812.30(a)(1). D. See 21 CFR 312.23(a)(7)(e) and 21 CFR 812.20(b)(9).

Which one of the following statements is NOT true with respect to both Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) for significant-risk products? A. The investigational product must be manufactured in full compliance with cGMP. B. Clinical studies must be reviewed and approved by an Institutional Review Board. C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise. D. The application must include an environmental impact statement that contains a claim for categorical exclusion or an environmental assessment.

A. The investigational product must be manufactured in full compliance with cGMP. Devices under approved IDEs are exempt from CGMP regulations except for design control requirements; investigational new drugs must be compliant with CGMP for finished pharmaceuticals. See 21 CFR 211.

Which one of the following statements is NOT true with respect to both Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) for significant-risk products? A. The investigational product must be manufactured in full compliance with cGMP. B. Clinical studies must be approved by an Institutional Review Board. C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise. D. The application must include an environmental impact statement that contains a claim for categorical exclusion or an environmental assessment.

A. The investigational product must be manufactured in full compliance with cGMP. Devices under approved IDEs are exempt from cGMP regulations except for design control requirements; investigational new drugs must be compliant with cGMP for finished pharmaceuticals (21 CFR 211).

All of the following are likely to trigger FDA to do a directed (for-cause) inspection of an investigator EXCEPT: A. The investigator conducts a several Phase 1 studies simultaneously. B. Monitoring by the IND Sponsor reveals underreporting of serious adverse events. C. Complaints about irregularities in control of investigational drug supplies. D. The investigator consistently reports results different from other investigators.

A. The investigator conducts a several Phase 1 studies simultaneously. Inspections may result from complaints, suspicion of false, fraudulent or unrealistic data, and failure to fulfill investigator responsibilities to protect the patients and control investigational products. See Koller, R.L., "FDA inspector Perspectives: GCPs and Insections of Clincal Investigators and Sponsors," SoCRA Source (May 2004); and 21 CFR312.60 General responsibilities of investigators.

If a device failure is occurring with greater than expected frequency and investigation of the problemimplicates improper use by the end user, which of the following typically occurs? A. The labeling is revised B. The product is recalled C. The product is redesigned D. A "Dear Doctor" letter is issued

A. The labeling is revised A. The labeling should provide appropriate information for proper use of the product. B. Improper use is not necessarily a reason for recall. C. Product redesign may be an appropriate option, but not an immediate rectification of the issue. D. A letter is appropriate, but not as a comprehensive corrective action.

If a device failure is occurring with greater than expected frequency and investigation of the problem implicates improper use by the end user, which of the following should occur? A. The labeling is revised B. The product is recalled C. The product is redesigned D. A "Dear Doctor" letter is issued

A. The labeling is revised The labeling should provide appropriate information for proper use of the product.

If a device failure is occurring with greater than expected frequency and investigation of the problem implicates improper use by the end user, which of the following typically occurs? A. The labeling is revised B. The product is recalled C. The product is redesigned D. A "Dear Doctor" letter is issued

A. The labeling is revised The labeling should provide appropriate information for proper use of the product.

If a device failure is occurring with greater than expected frequency and investigation of the problem indicated improper use by the end user, which of the following should occur? A. The labeling is revised B. The product is recalled C. The product is redesigned D. A "Dear Doctor" Letter is issured

A. The labeling is revised The labeling should provide appropriate information for proper use of the product. Regulatory Reference: 21 CFR 801

If a device failure is occurring with greater than expected frequency and investigation of the problem implicates improper use by the end user, which of the following typically occurs? A. The labeling is revised. B. The product is recalled. C. The product is redesigned. D. A "Dear Doctor" letter is issued.

A. The labeling is revised. The labeling should provide appropriate information for proper use of the product.

If a device failure is occurring with greater than expected frequency and investigation of the problem implicates improper use by the end user, which of the following typically occurs? A. The labeling is revised. B. The product is recalled. C. The product is redesigned. D. A "Dear Doctor" letter is issued.

A. The labeling is revised. The labeling should provide appropriate information for proper use of the product.

A company is developing a combination product that consists of a device that injects a specially formulated small molecule drug for pain into the muscle tissue. Which of the following describes the best US regulatory path: A. The product is regulated as a drug B. The product is regulated under CDRH C. The company should file a BLA to obtain US marketing approval D. The company should submit a request for designation to OCP

A. The product is regulated as a drug Primary mode of action is the pain drug and the device is a delivery system.

A company is developing a combination product that consists of a device that injects a specially formulated small molecule drug for pain into the muscle tissue. Which of the following describes the best US regulatory path: A. The product is regulated as a drug B. The product is regulated under CDRH C. The company should file a BLA to obtain US marketing approval D. The company should submit a request for designation to OCP

A. The product is regulated as a drug Primary mode of action is the pain drug and the device is a delivery system.

Once an Investigational New Drug (IND) is in effect, an amendment can be submitted for all the following EXCEPT: A. The sponsor intends to conduct a clinical investigation with an exception from Informed Consent for emergency research B. A change in a Phase 3 protocol that significantly affects the safety of subjects, the scope of the investigation or the scientific quality of the study C. Addition of a new investigator to carry out a previously submitted protocol D. Submission of new toxicology, chemistry or other technical information, or a report regarding the discontinuation of a clinical investigation

A. The sponsor intends to conduct a clinical investigation with an exception from Informed Consent for emergency research Whenever a sponsor intends to conduct a clinical investigation with an exception from Informed Consent for emergency research as set forth in 21 CFR 50.24, the sponsor shall submit to FDA a separate IND for such investigation. The other choices should be submitted as amendments to the IND.

A firm submitted a protocol and received IRB approval for a clinical trial involving children in which there would be no prospect of direct benefit to the individual subjects. On what basis could this study be approved by the IRB? A. The trial was likely to yield generalizable knowledge about the subject's disorder or condition and all other regulatory requirements were met. B. Parental consent was included in the IRB submission. C. The clinical investigation involved a less than minimal risk to the subjects. D. This trial should not have been approved.

A. The trial was likely to yield generalizable knowledge about the subject's disorder or condition and all other regulatory requirements were met. Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition, may be approved so long as all other regulatory requirements are met.

A sponsor of an IND must submit a telephone or facsimile safety report to the IND when then following conditions EXCEPT: A. There are findings from tests in laboratory animals of mutagenicity of the drug. B. The adverse event is both serious and unexpected. C. The adverse event is fatal or life-threatening. D. The adverse event is associated with the use of the drug.

A. There are findings from tests in laboratory animals of mutagenicity of the drug. Findings of mutagenicity in laboratory animals should be submitted in an IND safety report, but a telephone or facsimile report is not necessary; see 21 CFR 312.32(c).

While reviewing product complaint files for MDR reportability, you noticed a complaint regarding a common failure mode of an implantable screw. There was no patient involvement and no adverse consequences were reported in the complaint. Your firm has initiated a Class I recall for this implantable screw due to safety issues associated with this failure mode. As a regulatory professional your decision is: A. This complaint is reportable; an MDR will be filed with FDA within 30 days B. A review of the complaint history is needed to see whether such failure mode will likely cause or contribute to death or serious injury C. No MDR is needed as there is no patient involvement and no adverse consequences were reported D. No MDR is needed but you will file this complaint in the recall file

A. This complaint is reportable; an MDR will be filed with FDA within 30 days When a recall is initiated for a particular product failure mode, such failure mode is automatically MDR-reportable to FDA. Additionally, while the complaint did not report an adverse event, the manufacturer should evaluate the potential to cause an adverse event if the failure mode was to re-occur.

A company's competitor is marketing a Class II suture which dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. When can the company's new suture be marketed? A. This requires a new 510(k) since significant change in product instructions might affect efficacy. B. After submission in a periodic report C. After reporting clinical studies in an annual report D. After submission of labeling change

A. This requires a new 510(k) since significant change in product instructions might affect efficacy. A new intended use requires a 510(k) clearance.

Which or the following is NOT stipulated by FDA to support product postapproval stability requirements? A. Three batches per year per container closure system in the stability program B. An adequate number of batches C. An amount that is compliant with the postapproval stability commitment D. Reliable meaningful and specific test methods

A. Three batches per year per container closure system in the stability program

Which or the following is NOT stipulated by FDA to support product postapproval stability requirements? A. Three batches per year per container closure system in the stability program (FDA does not dictate exactly how much) B. An adequate number of batches C. An amount that is compliant with the postapproval stability commitment D. Reliable meaningful and specific test methods

A. Three batches per year per container closure system in the stability program (FDA does not dictate exactly how much)

If your company is planning for an IDE submission, the first thing you would suggest them to do to get FDA involved is: A. To plan a determination meeting with FDA B. To plan an agreement meeting with FDA C. To invite a FDA field officer to the facility D> None of the above

A. To plan a determination meeting with FDA

Your company would like to submit an IND for the use of a new drug on subjects with a life-threatening disease for which there are no suitable alternative drugs available. Which type of IND application would be most suitable for this type of investigation? A. Treatment IND B. Emergency Use IND C. Investigator IND D. Expanded access IND

A. Treatment IND A treatment IND would be most suitable for this application (answer 1). Treatment INDs are issued as a means of providing eligible subjects with investigational drugs or biologics for the treatment of serious and life-threatening illnesses for which there are no suitable alternative treatments.

For validated processes and systems, the possibility of revalidation should be considered for all of the following EXCEPT: A. When the manufacturer tightens the specification for container closure torque. B. Whenever there are changes in packaging, formulation, equipment, or processes which could impact product effectiveness or product characteristics C. When a change is made in raw material supplier D. Based on procedures in the Change Control Standard Operating Procedure.

A. When the manufacturer tightens the specification for container closure torque. Answers C and D are straight from the Guideline on General Principles of Process Validation, and CGMP calls for a change control process documented as an SOP as an element of the validation program.

When can the modified labeling format be used for an OTC product? A. When the required Drug Facts and other FDA required information exceed 60% of the total surface area available for labeling B. When the required Drug Facts and other FDA required information exceed 90% of the total surface area available for labeling C. When the manufacturer determines that the required drug facts and FDA required information do not fit within their label design D. When recommended by FDA after review of information in the label

A. When the required Drug Facts and other FDA required information exceed 60% of the total surface area available for labeling

From a subsidiary in Ireland, you are forwarded a report that a patient taking your drug was hospitalized with a case of Stevens-Johnson syndrome. This hypersensitivity reaction is not listed on your label. You should report this case to FDA: A. Within 15 calendar days of receipt B. Within 15 business days of receipt C. Within 10 business days of receipt D. With the next periodic adverse drug experience report

A. Within 15 calendar days of receipt

A medical device company discovers that a surgeon participating as a clinical investigator in an IDE study sponsored by the company has independently placed a video demonstrating the use of the investigational device on YouTube.com. Should this action be considered as misbranding by the manufacturer? A. Yes and the company should request removal of the video B. No as long as the surgeon makes no claims related to safety or efficacy of the device C. No but the device used in the video could be deemed adulterated D. Yes this may be considered as misbranded and adulterated.

A. Yes and the company should request removal of the video

The "Treatment JND" allows for which of the following? A. a promising investigational drug to be available to patients with serious or life-threatening conditions B. a sponsor to ship an unapproved product overseas for in-vitro diagnostic studies C. the sale of an unapproved product to the general public D. a previous~ "disqualified" investigator to become "reinstated", thereby allowing the investigator to conduct studies

A. a promising investigational drug to be available to patients with serious or life-threatening conditions A. The purpose of a Treatment IND is to facilitate the availability of promising new drugs to desperately ill patients prior to general marketing and to obtain additional data on the drug's safety and effectiveness. 21 CFR 312.34(a) B. In vitro diagnostics are defined as medical devices under 201 (h) of the FD&C Act. C. Under certain circumstances, a sponsor may charge for a Treatment IND drug with prior approval from FDA but this does not permit sale to the general public. 21 CFR 312.7(d)(2) D. This regulation, 21 CFR 312.34, Treatment IND, does not address reinstating disqualified clinical investigators.

Suppliers may be evaluated by on-site auditing of their quality programs. What is the best alternative to an on-site audit? A. a questionnaire covering the suppliers' quality program B. a statement from the supplier that a quality the supplier program is in place C. verification of supplier's ISO certification D. inspection of samples of material from the supplier

A. a questionnaire covering the suppliers' quality program A. A questionnaire, if carefully crafted, can provide a dear idea of the supplier's level of control and commitment to quality. B. A statement provides no information on the supplier's system. C. Although ISO certification is valuable, it does not ensure compliance with a quality program. D. Although inspection of material samples provide some information, it does not provide a sufficient or best level of information concerning the supplier's control system.

A regulatory affairs professional is developing SOPs for a firm to cover compliance with drug GMPs. The firms SOPs should require failure investigations to be completed within: A. a reasonable time B. 20 days C. 30 days D. 45 days

A. a reasonable time A. The regulations at 21 CFR 211.192 require an investigation, but do not specify a time frame. CDER policy states that "the investigation be conducted and reported in a reasonable time." B. An inspectional guide contains a 20-day time period, the Barr case contained a 30-day time frame, and a longer time may be appropriate, but should be clearly documented. C. See explanation B. D. See explanation B.

Under the statutory violations, lack of an approved PMA for a PMA device in commercial distribution is considered to be: A. adulteration B. improper use C. misbranded D. fraudulent

A. adulteration A. PMA products introduced into commercial distribution without an approval PMA are considered to be adulterated. FD&C Act 501(f). B. Proper or improper use is not a statutory violation. C. See explanation A. Misbranded is given to a product that is incorrectly labeled. D. See explanation A.

A personal deodorant manufacturer is required to do all of the following EXCEPT: A. comply with GMP B. state the place of business on the label C. list the quantity of contents on the label D. comply with export regulations when exporting product

A. comply with GMP A. Compliance to GMP is recommended, but not required for cosmetics. FD&C Act, Section 602(b). B. This is required by the regulations. Fair Packaging and Labeling Act, Section 4(a). C. An accurate statement of the quantity is required. Fair Packaging and Labeling Act, Section 4(a). D. The export regulations govern drug, devices and cosmetics. FD&C Act, Section 801(c).

According to the Quality System Regulation, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. device history record B. device master record C. complaint files D. design history file

A. device history record A. This contains the dates of manufacture, the quantity manufactured, the quantity released for distribution, control numbers used and the acceptance records which demonstrate the device is manufactured in accordance with the DMR. 21 CFR 820.184. B. This contains the device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance, and servicing procedures and methods 21 CFR 820.181. C. Complaint files comprise records of the investigation related to the complaint, or a record stating why no investigation was necessary. 21 CFR 820.198. D. The DHF contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan. 21 CFR 820.30(j).

A medical device is refused entry to the US. All of the following may be reasons for refusal EXCEPT for the lack of: A. establishment registration by the foreign manufacturer B. medical device listing by the foreign manufacturer C. substantially equivalent letter from FDA (510(k) clearance) D. establishment registration by the initial distributor

A. establishment registration by the foreign manufacturer A. Not all foreign manufacturers are not required to register. 807.40(a) / 807.65. B. Product listing is required for foreign manufacturers. C. Required under 301(p) of the FD&C Act. D. Initial distributors of foreign manufactured products are required to register. 807.20(a)(4).

Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C Act before marketing a device: A. makes the product misbranded under Section 502 of the Act B. introduces an unapproved product into interstate commerce C. causes the product to be mislabeled D. none of the above

A. makes the product misbranded under Section 502 of the Act A. The product is considered to be misbranded and adulterated if the product is not cleared through the 510(k) process. FD&C Act, Section 502(o) and 501(f)(1)(B). B. The 510(k) process is not an approval process. C. See explanation A. D. See explanation A.

All of the following are required for compliance to 21 CFR Part 11 (electronic records and electronic signatures) EXCEPT: A. manually generated, time-stamped audit trails to record the date and time of operator entries and actions that create, modify, or delete electronic records B. validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records C. authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand D. establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification

A. manually generated, time-stamped audit trails to record the date and time of operator entries and actions that create, modify, or delete electronic records A. Time-stamped audit trails must be secure, computer-generated records that independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Manually generated records are NOT acceptable. 21 CFR 11.10 (e). B. This is required under 21 CFR 11.10 (a). C. This is required under 21 CFR 11.10 (g). D. This is required under 21 CFR 11.10 (j).

The regulatory affairs practitioner performs all of the following prior to submitting a PMA to FDA EXCEPT: A. preparing criteria for the MDR report B. preparing a brief statement of reasons for noncompliance with regulation C. identifying all omissions in PMA content D. reviewing, organizing and checking adequacy of data pertaining to safety and efficacy evaluation

A. preparing criteria for the MDR report A. This requirement is for marketed products. MDR reporting is a post PMA approval requirement. B. This item is required by 814.20(b). C. See explanation B. D. This is good regulatory practice, and the regulatory affairs professional must certify the accuracy and completeness of all information submitted.

A GMP audit program must include auditing of: A. process validation programs. B. clinical studies files e. regulatory submissions. D. labeling claims.

A. process validation programs. A. Auditing of process validation programs are required in the Medical Device Quality System. 21 CFR 820.75. Process Validation and for prescription drugs, see Guidance for General Principles of Process Validation, May 1987. B. Oinical study files are not included in the GMP regulation. They are part of GCP regulation 21 CFR 812 and 211. C. Regulatory submission, labeling and labeling claims are currently reviewed by the reviewing Center and are not included in the GMP regulation. D. See explanation C.

Under IND regulations, obligations of a clinical study investigator include all of the following EXCEPT: A. providing a final study report to the IRB B. protecting the rights, safety and welfare of study subjects C. controlling the drug(s) under investigation D. retaining study related material for two years after NDA approval of the investigational drug for the indication studied

A. providing a final study report to the IRB A. The investigator is obligated to provide reports to the sponsor, not to the IRB. See 21 CFR 312.64. B. See 21 CFR 312.60. C. See 21 CFR 312.60 and 312.61. D. See 21 CFR 312.57(b) and 312.62(c).

The initial importer of a medical device must: A. register and submit device list to FDA B. maintain quality assurance files. C. share responsibility for submittals with other distributors. D. none of the above.

A. register and submit device list to FDA A. Distributors must list all initially imported devices with the FDA and establish themselves as device importers. 21 CFR 807.20 (c) . . B. QA records must be maintained by manufacturers and are not required by distributors. C. Section 51 O(k) of the FD&C Act does not require responsibility for a submission to be shared among distributors.

The initial importer of a medical device must: A. register and submit device list to FDA B. maintain quality assurance files C. share responsibility for submittals with other distributors D. report device malfunctions in an annual report

A. register and submit device list to FDA A. Distributors must list all initially imported devices with the FDA and establish themselves as device importers. 21 CFR 807.20(c). B. QA records must be maintained by manufacturers and are not required by distributors. C. Section 510(k) of the FD&C Act does not require responsibility for a submission to be shared among distributors. D. See explanation A.

A product has been developed and one key component/ingredient is manufactured by another company that will not provide its proprietary information about the part to the finished product manufacturer. To satisfy the NDA/PMA review process, the manufacturer can request the supplier to: A. submit a Drug/Device Master File B. file its own NDA/PMA C. supply appropriate sections of the NDA/PMA directly to FDA D. provide the manufacturer with certification that the supplier's proprietary information meets FDA requirements

A. submit a Drug/Device Master File A. This is the correct way for a supplier to provide access to FDA of proprietary information. 21 CFR 314.420, 21 CFR 814.3(d). B. This would be an incomplete submission. C. See explanation B. D. This would not provide the information required by FDA.

FDA has sent a warning letter citing mislabeling for a small manufacturer's artificial knee device. The regulatory affairs practitioner should first contact: A. the Compliance Branch in the district B. the Orthopedic Branch Chief in the CDRH Office of Device Evaluation C. the Division of Small Manufacturers Assistance in CDRH D. the CDRH Ombudsman

A. the Compliance Branch in the district A. This office is the best source for further follow-up. B. This is a compliance issue, not a device evaluation issue. C. This office will not assist in resolving active cases. D. The ombudsman handles dispute resolution between CDRH and a manufacturer and is only contacted after other avenues have been exhausted. The first warning letter a manufacturer receives does not fall into that category.

What are the three classifications of inspections for the Establishment Inspection Report (EIR)? A. Require Action Indicated B. No Action Indicated C. Voluntary Action Indicated D. Official Action Indicated E. Mandatory Action Indicated

B C and D

An FDA Form 1572 Statement of the Investigator should be revised for all of the following except: A) A change in the principal investigator for the study B) A change in sponsor's medical monitor for the study C) The addition of a local lab or health care facility to which the study patients make visits D) A change in the IRB or the IRB's name

B) A change in sponsor's medical monitor for the study The sponsor medical monitor is recorded on the 1571 in box 14 not part of Form 1572

GLP documentation archives should have the following attributes except: A) Appropriate for laboratory specimens B) Accessible to all facility personnel C) Environmentally controlled (temperature and humidity) D) Secure with controlled access to raw data and documentation

B) Accessible to all facility personnel - access should be limited to authorized personnel

Management should be notified in writing of the GMP Investigations conducted for all of the following except: A) Product Complaints B) Batch Production Record documentation corrections C) Returned Drug Products D) Drug Product Salvaging

B) Batch Production Record documentation corrections (least severe/critical)

510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: A) High Flux Hemodialyzer B) Blood specimen collection device C) Piston syringe D) Cardiopulmonary bypass blood tubing

B) Blood specimen collection device This is a recall question related to the proper Center and proper type of submission required for market clearance

An liquid-filled teething ring (for use by infants) is an example of what type of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device

B) Class 2 Class 2 (Exempt from pre-market notification procedure) Class 1 if not liquid filled Sec. 872.5550 Teething ring. - Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process. - Classification. - Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. - Class II if the teething ring contains a fluid, such as water. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

A male condom is an example of what class of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device

B) Class 2 Meet performance standards Same class if condom has or does not have spermicidal lubricant, different CFR reference Sec. 884.5300 Condom. - Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of venereal disease). The device may also be used to collect semen to aid in the diagnosis of infertility. - Classification. Class II (performance standards).

An OTC denture repair kit (powder and liquid glue) intended for permanent repair of cracks is an example of what type of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device

B) Class 2 Special controls are FDA's "Use of International Standard ISO 10993 'Biological Evaluation of Medical Devices...' and "OTC denture reliners, repair kits, partially fabricated denture kits Sec. 872.3570 OTC denture repair kit. - Identification. An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. - Classification. Class II. The special controls for this device are FDA's: - "Use of International Standard ISO 10993 `Biological Evaluation of Medical Devices--Part I: Evaluation and Testing,' " and - "OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits." [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000]

An acupuncture needle is an example of what kind of device? A) Class 1 B) Class 2 C) Class 3 D) Not a device

B) Class 2 Special controls: Label for single use only conformance to requirements for prescription devices Device material biocompatibility Device sterility Sec. 880.5580 Acupuncture needle. - Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment. - Classification. Class II (special controls). - Acupuncture needles must comply with the following special controls: - Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, - Device material biocompatibility, - Device sterility.

The Quality System Regulation (QSR) for medical devices regarding Design Controls require which of the following: A) Documentation of early research of the design B) Design and development plans address how design inputs and requirements are managed C) A product design can be outsourced by a manufacturer so they do not have to maintain the documentation D) Design activities are only required for Class III Investigational devices

B) Design and development plans address how design inputs and requirements are managed

The MDR regulations require that which of the following groups are not required to notify FDA if they become aware of information required to be reported. A) Manufacturers B) Distributors C) Initial importers D) User facilities

B) Distributors Distributors are not required to report to FDA

According to GMPs, the following product labels should be rejected except which of the following: A) Labeling and packaging materials that do not meet the approved specifications B) Gang printed labeling C) Obsolete and outdated labels D) Labeling and packaging materials stamped with the lot number remaining at the end of a production run

B) Gang printed labeling Gang printed labeling means labeling derived from printed material on which more than one item of labeling is printed - there are special controls on this type of label to avoid errors

According to GMPs, the following product labels should be rejected except which of the following: A) Labeling and packaging materials that do not meet the approved specifications B) Gang-printed labeling C) Obsolete and outdated labels D) Labeling and packaging materials stamped with the lot number remaining at the end of a production run

B) Gang-printed labeling Gang printed labeling means labeling derived from printed material on which more than one item of labeling is printed - there are special controls on this type of label to avoid errors D) Incorrect - should be rejected - lot finished, label cannot be re-used

Which of the following is true regarding ICH guidelines? A) ICH guidelines represent the joint opinions of regulatory agencies in US, Europe and Japan B) ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe and Japan C) ICH guidelines represent the joint opinions of the pharmaceutical industry in US, Europe and Japan D) ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe, Canada and Japan

B) ICH guidelines represent the joint opinions of the pharmaceutical industry and regulatory agencies in US, Europe and Japan

Which of the following medical device types are not subject to Manufacturer tracking: A) Life-sustaining or life-supporting device used outside of a device-user facility B) Life-sustaining or life-supporting device used inside of a device-user facility C) Permanently implantable device D) Devices sold to a distributor for ultimate delivery (sale) to end-user

B) Life-sustaining or life-supporting device used inside of a device-user facility Tracking System Includes: -Current records in accordance with manufacturer's Standard Operating Procedures -For as long as device is in use or in distribution for use -Provide for data collection and recording, including when & why required data is missing -Method for tracking changes to tracking system -Audit for each device at not less than 6-month intervals for first 3 years of distribution & annually thereafter FDA can order tracking of other devices and will do so in the clearance or approval letter that you receive following your 510(k) or PMA clearance or approval -Within 3 working days of FDA request report the following data: Name, address and phone # of distributor holding device for distribution and location of device -Within 10 working days of FDA request report the following data: Lot, batch, model or serial # providing effective tracking -Date device was shipped from manufacturer

GLP study directors are required to conduct the following activities except: A) Approving the final study reports B) Maintenance of the master schedule C) The protocol is approved and followed D) Experimental data are accurately reported and verified

B) Maintenance of the master schedule - QA responsible

Which of the following conditions may be expected to lead to a field recall action? A) Market Withdrawal for correction or removal of distributed devices involving no violation or minor violation of Federal Food, Drug & Cosmetic Act B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection C) Stock Recovery of a device has not left direct control of manufacturer D) Routine servicing

B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection Market Withdrawal Correction or removal of distributed devices involving minor violation or no violation (i.e., normal stock rotation) Removal Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection Stock Recovery Device has not been marketed or has not left direct control of manufacturer Routine servicing (meaning regularly scheduled) does not include unexpected repairs or identical replacements of multiple units

The following are objectives of a pre-approval inspection except: A) Assess cGMP compliance B) Scientific review of data to assess safety and efficacy C) Collect samples for analysis by FDA D) Verify accuracy of data submitted in an application

B) Scientific review of data to assess safety and efficacy pre-approval inspection does NOT include a scientific review of data to assess safety and efficacy; this is a responsibility of the review division

In the clinical development plan for an investigational anti-hypertensive drug, which of the following studies will typically be conducted first? A) 1 month repeat dose toxicology study B) Single dose escalation PK study in healthy volunteers C) Multiple dose PK study in healthy volunteers D) Single dose escalation study in hypertensive patients

B) Single dose escalation PK study in healthy volunteers Eliminate A because it is a preclinical study and the question is asking for a clinical study. Eliminate D as you would typically start with a healthy volunteer population Eliminate C as you would typically start with single dose and follow with multiple dose

Under the official definition of a "device", all of the following are considered devices except: A) X-ray film B) Sterilizers used for device manufacturing C) Eyeglass lenses and frames D) In vitro diagnostic kit

B) Sterilizers used for device manufacturing Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. - Eyeglass frames, 886.5842 - Lenses, spectacle, 886.5844 -Sunglasses, non-prescription, 886.5850

Your company wants to conduct a small exploratory study for an alternate dosing regimen for an approved drug/approved indication. As a Regulatory Affairs professional, your first advice is: A) The results of the study may potentially be useful to support a label change B) The study must be conducted under an IND C) You cannot conduct the study unless you intend to pursue a label change D) Increase the size of the study in order to demonstrate statistical significance

B) The study must be conducted under an IND Key word is alternate dosing regimen, exploratory study. You might also think A) and D) but the best answer is B, this should be your first consideration as a regulatory affairs professional -An IND is required if the drug is to be studied "off label", e.g., alternate dosing regimen, different indication, different formulation (21 CFR 312) -If the study is conducted under an IND, results of the study may support a supplement for the alternate dosing regimen, i.e., label change -An exploratory study unlikely to support label change unless safety concern is observed -Assuming study is conducted under an IND... sponsor's choice whether to conduct small or large study. A decision based on risk, budget, etc

As the sponsor of an approved drug product, you receive information that your distributed product is exhibiting unexpected properties suggesting chemical, physical, or bacteriological change. You are required to report this information as follows: A) Within 7 calendar days to the local FDA district office B) Within 3 working days to the local FDA district office C) In the annual report D) Within 15 calendar days to reviewing FDA office

B) Within 3 working days to the local FDA district office NDA Field Alert Report Within 3 working days of receipt, applicant must submit to the local FDA district office: -Information concerning any incident that causes the drug or its labeling to be mistaken for or applied to another article -Information concerning any incident of chemical, physical, bacteriological change in distributed drug product or any failure of one or more distributed batches to meet established

A sponsor must report an unexpected, fatal or life-threatening experience believed to be associated with an unapproved drug/biologic: A) to FDA, investigators and IRBs within 7 calendar days B) to FDA within 7 calendar days C) to FDA within 14 calendar days D) to FDA and investigators within 7 working days

B) to FDA within 7 calendar days The sponsor is responsible for reporting to FDA and investigators Investigators are responsible to communicate with their respective IRBs The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study. Eliminate A and C; neither reflect basic sponsor reporting obligations. Now choose between 7 calendar days or 7 working days. B is the best answer. Note that sponsor reporting to investigators is not tied to the 7 day report process. Investigators are notified usually based on the 15 day report since this generally has more information.

Fully quality-assured individual toxicology reports are not required for submission of an initial IND application. Instead, an integrated summary report may be submitted. However, finalized and updated reports and/or an updated integrated summary report should be available to FDA upon request within what period of the start of the human study? A. 90 days B. 120 day C. One year D. The final report is only required in the submission for the NDA.

B. 120 day See FDA's Guidance for Industry: Q & A: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products, October 2000.

Fully quality-assured individual toxicology reports are not required for submission of an initial IND application. However, finalized and updated reports should be available to FDA upon request within what period of the start of the human study? A. 90 days B. 120 days C. One year D. The final report is only required in the submission for the NDA

B. 120 days

Fully quality-assured individual toxicology reports are not required for submission of an initial IND application; however, finalized and updated reports should be available to FDA upon request within what period of the start of the human study? A. 90 days B. 120 days C. One year D. The final report is only required in the submission for the NDA.

B. 120 days B. See FDA "Guidance for Industry Q & A: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products." October 2000.

Fully quality-assured individual toxicology reports are not required for submission of an initial IND application. However, finalized and fully quality assured reports should be available to FDA upon request within what period of the start of the human study? A. 90 days. B. 120 days. C. One year. D. The final report is only required in the submission for the NDA.

B. 120 days. See FDA "Guidance for Industry Q & A: Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products." October 2000.

A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and patient Medication Guide in annotated Word format for initial FDA review, and committed to submit the Labeling in Structured Product Label (SPL) format upon approval of their product. What is the preferred timeline for this pharmaceutical company to submit the SPL formatted labeling upon product approval? A. 7 days B. 14 days C. 30 days D. 60 days

B. 14 days

A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and patient Medication Guide in annotated Word format for initial FDA review, and committed to submit the Labeling in Structured Product Label (SPL) format upon approval of their product. What is the preferred timeline for this pharmaceutical company to submit the SPL formatted labeling upon product approval? A. 7 days B. 14 days C. 30 days D. 60 days

B. 14 days "13. If the content of labeling is approved based on the draft SPL, when should the final SPL be submitted after approval? The final SPL should be submitted preferably within 14 calendar days after approval or as soon as possible thereafter." But in practice, FDA stipulates to submit SPL "As soon as possible, but no later than 14 days from the date of approval letter"

A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert (PI) and patient Medication Guide in annotated Word format for initial FDA review, and committed to submit the Labeling in Structured Product Label (SPL) format upon approval of their product. What is the preferred timeline for this pharmaceuticalcompany to submit the SPL formatted labeling upon product approval? A. 7 days B. 14 days C. 30 days D. 60 days

B. 14 days "13. If the content of labeling is approved based on the draft SPL, when should the final SPL be submitted after approval? The final SPL should be submitted preferably within 14 calendar days after approval or as soon as possible thereafter." But in practice, FDA stipulates to submit SPL "As soon as possible, but no later than 14 days from the date of approval letter"

A minimum of 10 tablets is required to perform all tests for product release. To meet GMP requirements, retention samples must be at least: A. 10 tablets B. 20 tablets C. 30 tablets D. 100 tablets

B. 20 tablets A. This is not a sufficient amount. B. The reserve sample consists of at least twice the quantity necessary for each required test. 21 CFR 211.170(a).

A minimum of 10 tablets is required to perform all tests for product release. To meet GMP requirements, reserve samples must be at least: A. 10 tablets B. 20 tablets C. 30 tablets D. 100 tablets

B. 20 tablets The reserve sample consists of at least twice the quantity necessary for each required test; see 21 CFR 211.170(a).

A minimum of 10 tablets is required to perform all tests for product release. To meet GMP requirements, retention samples must be at least: A. 10 tablets. B. 20 tablets. C. 30 tablets. D. 100 tablets.

B. 20 tablets.

A minimum of 10 tablets is required to perform all tests for product release. To meet GMP requirements, reserve samples must be at least: A. 10 tablets. B. 20 tablets. C. 30 tablets. D. 100 tablets.

B. 20 tablets. The reserve sample consists of at least twice the quantity necessary for each required test. 21 CFR 211.170(a).

The term of a new patent is: A. 20 years from date of NDA approval B. 20 years from the date of filing for the patent C. 14 years from date of NDA approval D. 14 years from the date of filing for the patent

B. 20 years from the date of filing for the patent

Regulations regarding INDs are codified in: A. 21 CFR 210 B. 21 CFR 312 C. 21 CFR 314 D. 21 CFR 320

B. 21 CFR 312

Which one of the following is referred to as "new clinical investigation" or "new use" exclusivity: A. 5 year exclusivity B. 3 year exclusivity C. Pediatric exclusivity D. Orphan exclusivity

B. 3 year exclusivity

If an NDA holder sues a ANDA applicant that submits Paragraph IV certification, the ANDA application delays for: A. 30 days B. 30 months C. 45 days D. 60 days

B. 30 months

The timeline for submitting a briefing document is different for different types of FDA meeting. For a type B meeting, the briefing document should be submitted at least A. 2 weeks prior to meeting B. 4 weeks prior to meeting C. 6 weeks prior to meeting D. 8 weeks prior to meeting

B. 4 weeks prior to meeting

After submission of an NDA, FDA will make decisions within X days if they will file the NDA. A. 30 days B. 60 days C. 45 days D. 6 months

B. 60 days

Annual reports for ANDAs must be submitted within _____ days for the anniversary of the application aaproval date on Form_____? A. 30 days; Form 356h B. 60 days; Form 2252 C. 60 days; Form 1571 D. 30 days; Form 2252

B. 60 days; Form 2252

Which of the following is NOT TRUE regarding the recall of a product from the market that is deemed to be in violation of FDA laws: A. The classification for a recall (I, II, III) is assigned by the FDA. B. A Class I recall is for the highest level of risk associated with the product. C. FDA can mandate a company to recall its marketed product. D. A recall is intended to protect the consumer.

B. A Class I recall is for the highest level of risk associated with the product. Recall is not risk based its based on serious adverse health events A Class I recall has the highest risk classification associated with the recall itself. See 21 CFR 7.3(m)

A medical device company is developing a product with drug, biologic and device components. The product and indication have not been classified previously by FDA. What is the most appropriate regulatory pathway? A. An IDE and PMA should be submitted to CDRH, as the company is a medical device company and is most familiar with medical device application regulations B. A Request for Designation (RFD) should be sent to the Office of Combination Products (OCP) at FDA to determine the primary mode of action (PMOA) and assign the center with primary jurisdiction C. An IND and NDA should be submitted to CBER because this is the strictest regulatory pathway D. The company should submit a marketing application to the appropriate FDA center based on the company's determination of primary mode of action (PMOA)

B. A Request for Designation (RFD) should be sent to the Office of Combination Products (OCP) at FDA to determine the primary mode of action (PMOA) and assign the center with primary jurisdiction An unclassified, combination product should be evaluated by OCP through the RFD process to determine the primary mode of action. An RFD also is referred to as an applicant's letter of request (see 21 CFR 3.2(j)). It is a written submission to OCP. RFDs generally request a determination of (1) the regulatory identity or classification of a product as a drug, device, biological product or combination product.

A medical device company is developing a product with drug, biologic and device components. The Product and indication have not been previously classified by FDA. What is the most appropriate regulatory pathway? A. An IDE and PMA should be submitted to CDRH, as the company is a medical device company and is most familiar with medical device application regulations B. A Request for Designation RFD should be sent to the Office of Combination Products (OCP) at FDA to determine the Primary Mode of Action (OMOA) and assign the Agency with primary jurisdiction C. An IND and NDA should be submitted to CBER because this is the strictest pathway D. The company should submit marketing application to the FDA center based on the company's determination of primary mode of action (PMOA)

B. A Request for Designation RFD should be sent to the Office of Combination Products (OCP) at FDA to determine the Primary Mode of Action (OMOA) and assign the Agency with primary jurisdiction

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? A. A PMA B. A Special 510(k) C. An Individual Device Exemption (IDE) D. An Annual Report for a PMA

B. A Special 510(k) The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission also should reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements. Manufacturers of Class I devices requiring 510(k)s may elect to comply with the design control provision of the Quality System Regulation and submit Special 510(k)s.

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? A. A PMA B. A Special 510(k) C. An Individual Device Exemption (IDE) D. An Annual Report for a PMA

B. A Special 510(k) The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission also should reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements. Manufacturers of Class I devices requiring 510(k)s may elect to comply with the design control provision of the Quality System Regulation and submit Special 510(k)s.

The marketing department has designed a journal advertisement which mentions the leadership in a particular therapeutic area and includes only the name of the company's approved prescription drug products. Which of the following should be included in the advertisement to be in compliance with regulations? A. Full prescribing information B. A brief summary of the prescribing information C. Clinical data must be referenced D. A complete listing of adverse events

B. A brief summary of the prescribing information A. This is not required for this advertisement. B. This is required because the product and therapeutic area are mentioned. 21 CFR 202(e)(1). C. See explanation A. D. This is only partially correct. See explanation B. All advertisements for any prescription drug as regulated under 21 CFR 202.1(e)(1) require providing a true statement of information in brief summary relating to side effects, contraindications and effectiveness. This is required because the product and therapeutic area are mentioned.All advertisements for any prescription drug as regulated under 21 CFR 202.1(e)(1)require providing a true statement of information in brief summary relating to side effects, contraindications and effectiveness.

25. Once an investigation New Drug (IND) is in effect, an amendment can be submitted for all the following EXCEPT: A. The sponsor intends to conduct a clinical investigation with an exception from informed consent for emergency research B. A change in a Phase 3 protocol that significantly affects the safety of the subject, the scope of the investigation or the scientific quality of the study C. When a new investigator is added to carry out a previously submitted protocol D. Submission of new toxicology, chemistry or other technical information, or a report regarding the discontinuation of a clinical investigation

B. A change in a Phase 3 protocol that significantly affects the safety of the subject, the scope of the investigation or the scientific quality of the study

According to FDA, which of the following materials is not considered labeling? A. Package insert for patient B. A drug commercial piece on a published journal C. Drug information posted on internet by the manufacturer D. Audio matter descriptive of a drug for pharmacists

B. A drug commercial piece on a published journal The term "labeling" is a broad term. It includes professional labeling (package inserts), patient package inserts and promotional labeling. Further, 21 CFR 202.1(1)(1) describes advertisement in "published journals, other periodicals and newspapers...", while 21 CFR 202.1(1)(2) describes examples of promotional labeling. Additionally, Internet is considered promotional labeling rather than advertising.

A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this technology and special controls have been established. This change would be best filed as a(n): A. Special 510(k) B. Abbreviated 510(k) C. Traditional 510(k) D. PMA

B. Abbreviated 510(k)

A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this technology and special controls have been established. This change would be best filed as a(n): A. Special 510(k). B. Abbreviated 510(k). C. Traditional 510(k). D. PMA.

B. Abbreviated 510(k). An abbreviated 510(k) is allowed in this case because there is a published guidance and special controls for the device exist. The abbreviated 510(k) route may allow for a more expeditious review by the FDA than a traditional 510(k). See the CDRH guidance published in 1998 entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".

PMA supplements requiring pre-approval include the following except: A. A new indication for use B. Addition of QC test methods C. Extension of shelf life D. A change in the facility used to manufacture the device

B. Addition of QC test methods

A medical device company has received a Warning Letter because mold has been found in two batches of its product. The letter cites that the product is: A. Quarantined B. Adulterated C. Misbranded D. Fraudulent

B. Adulterated A device that fails to comply with the QSR (GMP) regulations set forth in 21 CFR 820 is considered adulterated.

What is the formal early collaboration meeting that was implemented through the Food and Drug Administration Modernization Act (FDAMA)? A. PDP meeting B. Agreement Meeting C. Pre-IDE meeting D. Type A meeting

B. Agreement Meeting The Agreement Meeting is a formal meeting to agree on the parameters of the investigational plan. When a meeting request is received by FDA, the meeting will be held within 30 days. The agreements made at the meeting are provided in writing to the sponsor and are binding on FDA.

What is the formal early collaboration meeting that was implemented throught the Food and Drug Modernization Act (FDAMA)? A. PDP Meeting B. Agreement Meeting C. Pre-IDE Meeting D. Pre-PMA Meeting

B. Agreement Meeting The Agreement Meeting is a formal meeting to agree upon the parameters of the investigational plan. When a meeting request is received by FDA, the meeting will be held within 30 days. The agreements made at the meeting are provided in writing to the sponsor and are binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry and for CDRH Staff (February 2001).

Company X is planning to conduct a bioequivalence (BE) study for its proposed generic drug product. The clinical protocol requires a multiple-dose study where the total daily dose exceeds that specified in the labeling of the reference approved drug product. As a regulatory professional, which choice below is the correct action concerning this bioequivalence study? A. The bioequivalence study may be started without further FDA action since the drug product is already the subject of an approved NDA. B. An Investigational New Drug Application (IND) must be filed prior to initiating the BE study C. Request a Type B meeting with FDA for protocol review and approval D. Submit a suitability petition requesting the use of the increased dosage range

B. An Investigational New Drug Application (IND) must be filed prior to initiating the BE study As per regulation, an IND application is required for a multiple-dose study in normal subjects or patients where either the single or total daily dose exceeds that specified in the labeling of the drug product that is the subject of an approved NDA or ANDA.

Company X is planning to conduct a bioequivalence (BE) study for its proposed generic drug product. The clinical protocol requires a multiple-dose study where the total daily dose exceeds that specified in the labeling of the reference approved drug product. As a regulatory professional, which choice below is the correct action concerning this bioequivalence study? A. The bioequivalence study may be started without further FDA action since the drug product is already the subject of an approved NDA. B. An Investigational New Drug Application (IND) must be filed prior to initiating the BE study C. Request a Type B meeting with FDA for protocol review and approval D. Submit a suitability petition requesting the use of the increased dosage range

B. An Investigational New Drug Application (IND) must be filed prior to initiating the BE study As per regulation, an IND application is required for a multiple-dose study in normal subjects or patients where either the single or total daily dose exceeds that specified in the labeling of the drug product that is the subject of an approved NDA or ANDA.

In order to ensure that a facility complies with GMP requirements, all of the following features should be evaluated EXCEPT: A. Air handling system B. Animal supply facilities C. Lighting D. Potable water

B. Animal supply facilities Evaluation of animal supply facilities does not fall under GMP, but rather falls under GLP, 21 CFR 58.45.

In order to ensure that a facility complies with GMP requirements, all of the following features should be evaluated EXCEPT: A. Air handling system. B. Animal supply facilities. C. Lighting. D. Potable water.

B. Animal supply facilities. Evaluation of animal supply facilities does not fall under GMP, but rather falls under GLP, 21 CFR 58.45.

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. Quality audits conducted by individuals who do not have direct responsibility for the operation being audited B. Annual audits of operations C. Documenting the dates and results of quality audits and re-audits D. Having findings reviewed by management responsible for the matters audited

B. Annual audits of operations FDA recommends periodic audits and does not specify a time.

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. Quality audits conducted by individuals who do not have direct responsibility for the operation being audited. B. Annual audits of operations C. Documetn the dates and results of quality audits and re-audits D. Have findings reviewed by management responsible for the matters audited

B. Annual audits of operations. FDA recommends periodic audits and does not specify a time. Regulatory Reference: 21 CFR 820.3(22)

Your company's drug product is a little yellow pill. A pharmacist tells a sales rep that several customers complained that your little yellow pill looks a lot like another other little yellow pill. One customer explained how they took the wrong pill and got very dizzy. The sales rep informs you about those complaints. How should this be reported to FDA? A. As a FIELD Alert report sent within 15 days B. As a FIELD Alert report sent within three days C. As an Annual Report D. As a distribution data report

B. As a FIELD Alert report sent within three days Rapid communication methods are utilized to provide the information the drug product has been mistaken for another article.

Your company is making a change to a specification in order to comply with an official compendium of an NDA product. How should this change be reported? A. In a CBE-30 due to the moderate potential of the change to have an adverse effect B. As an update in the next Annual Report C. In a new letter of authorization D. There is no need to report this change

B. As an update in the next Annual Report Minor Changes (Annual Report) The following are examples of changes in specifications considered to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. Any change in a specification made to comply with an official compendium, except the changes described in section VIII.C.1.e, that is consistent with FDA statutory and regulatory requirements (§ 314.70(d)(2)(i)). For compendial drug products approved under an NDA or ANDA, changes made to the specifications in the approved application regarding General Chapter <467> should be in accordance with applicable regulations described in 21 CFR 314.70 and the recommendations in the guidance for industry on Changes to an Approved NDA or ANDA. Generally, an Annual Report, if needed, can be used to report changes such as adding a test to a finished product pecification or adding an alternative analytical procedure to a specification to comply with the USP.

A company has just received FDA approval to market a new drug. When must the drug sponsor submit the content of labeling in structured product labeling (SPL) format using the FDA automated drug registration and listing system? A. As soon as possible, but no later than 30 days in advance of the intended marketing date of the product B. As soon as possible, but no later than 14 days from the date of the FDA approval letter C. As soon as possible, but no later than 14 days from the first day the product is marketed D. As soon as possible, but no later than 30 days from the date of the FDA approval letter

B. As soon as possible, but no later than 14 days from the date of the FDA approval letter NDA approval letters say "As soon as possible, but no later than 14 days from the date of this letter..."

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. Conduct quality audits by individuals who do not have direct responsibility for the operation being audited B. Audit operations annually C. Document the dates and results of quality audits and re-audits D. Have findings reviewed by management responsible for the matters audited

B. Audit operations annually Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency to determine that quality system activities comply with quality system procedures that these procedures are implemented effectively and that procedures are suitable to achieve quality system objectives.

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. Conduct quality audits by individuals who do not have direct responsibility for the operation being audited B. Audit operations annually C. Document the dates and results of quality audits and re-audits D. Have findings reviewed by management responsible for the matters audited

B. Audit operations annually Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency to determine that quality system activities comply with quality system procedures that these procedures are implemented effectively and that procedures are suitable to achieve quality system objectives.

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. Conduct quality audits by individuals who do not have direct responsibility for the operation being audited. B. Audit operations annually. C. Document the dates and results of quality audits and re-audits. D. Have findings reviewed by management responsible for the matters audited.

B. Audit operations annually.

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. Conduct quality audits by individuals who do not have direct responsibility for the operation being audited. B. Audit operations annually. C. Document the dates and results of quality audits and re-audits. D. Have findings reviewed by management responsible for the matters audited.

B. Audit operations annually. False. Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency to determine that quality system activities comply with quality system procedures that these procedures are implemented effectively and that procedures are suitable to achieve quality system objectives.

During a review of the production records for Batch 1 of Drug Product X, it was discovered the theoretical yield exceeded the maximum percentage established in the master production and control records by 1.5%. The batch has not been distributed. As a regulatory professional, you should recommend the investigation: A. Be extended to only other batches of Drug Product X B. Be extended to other drug products that may have been associated with the discrepancy C. No immediate action is needed but the discrepancy should be noted in the next Annual Report D. Further production should be halted until the reason for the discrepancy is identified

B. Be extended to other drug products that may have been associated with the discrepancy Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed.

A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a microhematocrit analyzer that, among other intended uses, can determine the hematocrit of a blood donor prior to donation of a blood product. The firm should address the 510(k) submission to: A. CDER B. CBER C. CDRH D. OCP

B. CBER This agreement describes those product characteristics or medical indications that require a collaborative review effort by the two centers and the regulatory jurisdiction for biologic product and medical devices is clearly stated. Intercenter Agreement between CBER and CDRH. VI. Medical Devices for which CBER will have lead responsibility. CBER also has the responsibility for regulating all in vitro tests (including diagnostic tests which are not performed in association with blood bank practices).

Which FDA center should have jurisdiction for the premarket review and regulation of a nasal spray single-entity combination product that uses a drug as its PMOA? A. CDRH B. CDER C. CBER D. CDRH and CDER

B. CDER

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital and may suffer further reversible medical consequences as a result of the defective product. If this product is recalled from the market, which of the following recall classifications would most likely be assigned? A. Class I B. Class II C. Class III D. Class IV

B. Class II A. Exposure to this product is likely to cause death or serious injury. B. Exposure to this product may cause temporary or medically reversible adverse health consequences. 21 CFR 7.3(m). C. Exposure to this product is not likely to cause an adverse health consequence. D. This is not a classification in the regulations.

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital for reversible medical consequences as a result of the defective product. What type of recall classification would be assigned to this product. A. Class I B. Class II C. Class III D. Class IV

B. Class II Exposure to this product may cause temporary or medically reversible adverse health consequences. Regulatory Reference: 21 CFR 7.3; 21 CFR 7.41

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital and may suffer further reversible medical consequences as a result of the defective product. If this product is recalled from the market, which of the following recall classifications would most likely be assigned? A. Class I B. Class II C. Class III D. Class IV

B. Class II Exposure to this product may cause temporary or medically reversible adverse health consequences; see 21 CFR 7.3(m).

An analyte specific reagent used for blood banking tests would be considered: A. Class II, labeled as "Analyte Specific Reagent. Analytical and performance characteristics are not established". B. Class II, labeled as "Analyte Specific Reagent. Except as a component of the approved/cleared test (Name of approved/ cleared test), analytical and performance characteristics of this ASR are not established." C. Class III, labeled as "For Laboratory Use." D. Class III, labeled as "Analyte Specific Reagent. Except as a component of the approved/cleared test (Name of approved/ cleared test), analytical and performance characteristics of this ASR are not established."

B. Class II, labeled as "Analyte Specific Reagent. Except as a component of the approved/cleared test (Name of approved/ cleared test), analytical and performance characteristics of this ASR are not established."

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital and may suffer further reversible medical consequences as a result of the defective product. If this product is recalled from the market, which of the following recall classifications would most likely be assigned? A. Class I. B. Class II. C. Class III. D. Class IV.

B. Class II. Exposure to this product may cause temporary or medically reversible adverse health consequences 21 CFR 7.3(m).

Inspections of device components received from a supplier may frequently reveal product quality deficiencies. To avoid these instances, the supplier should first have: A. Expert GMP knowledge B. Clear and precise specifications from the manufacturer C. Detailed knowledge of the manufacturer's operations D. An internal audit program

B. Clear and precise specifications from the manufacturer An agreement outlining the manufacturer's specifications would minimize quality deficiencies. 21 CFR 820.81(b).

Inspections of device components received from a supplier may frequently reveal product quality deficiencies. To avoid these instances, the supplier should first have: A. Expert GMP knowledge. B. Clear and precise specifications from the manufacturer. C. Detailed knowledge of the manufacturer's operations. D. An internal audit program.

B. Clear and precise specifications from the manufacturer. An agreement outlining the manufacturer's specifications would minimize quality deficiencies. 21 CFR 820.81(b).

You work for a German-based device manufacturer (Company A) that produces a power supply based on the design of a US-based medical device company (Company B). The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the US-based medical device company (Company B) for final assembly. Which company needs to register with FDA: A. Company A B. Company B C. Company A &B D. Company A, B &C

B. Company B Company A qualifies as a foreign component manufacturer and as such, does not require establishment registration under 21 CFR 807.65(a). Company C is the initial imported of a component and does not need register under 21 CFR 807.20.

You work for a German-based device manufacturer (Company A) that produces a power supply based on the design of a US-based medical device company (Company B). The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the US-based medical device company (Company B) for final assembly. Which company needs to register with FDA: A. Company A B. Company B C. Company A &B D. Company A, B &C

B. Company B Company A qualifies as a foreign component manufacturer and as such, does not require establishment registration under 21 CFR 807.65(a). Company C is the initial imported of a component and does not need register under 21 CFR 807.20.

Company X has conducted clinical studies to support the safety and effectiveness of drug A. Company X is planning to develop a new dosage formulation with a new route of administration for drug A. This new formulation will rely on the clinical studies that support the drug A's safety and effectiveness. Which of the following is true? A. Company X should submit a 505(b)(2) application B. Company X should submit an NDA containing full reports of investigations of safety and effectiveness C. Company X should submit a 505(j) application D. Company X should submit an efficacy supplement

B. Company X should submit an NDA containing full reports of investigations of safety and effectiveness The clinical studies were conducted by the applicant. A new dosage formulation with a new route of administration will require an NDA.

Company X has conducted clinical studies to support the safety and effectiveness of drug A. Company X is planning to develop a new dosage formulation with a new route of administration for drug A. This new formulation will rely on the clinical studies that support the drug A's safety and effectiveness. Which of the following is true? A. Company X should submit a 505(b)(2) application B. Company X should submit an NDA containing full reports of investigations of safety and effectiveness C. Company X should submit a 505(j) application D. Company X should submit an efficacy supplement

B. Company X should submit an NDA containing full reports of investigations of safety and effectiveness The clinical studies were conducted by the applicant. A new dosage formulation with a new route of administration will require an NDA.

Company ABC is planning to move its manufacturing process to a new clinical manufacturing site. The product is a biologic and is currently in a Phase 2 clinical study. Once the manufacturing site is validated, it will produce material for the planned Phase 3 pivotal study. What sort of comparability data would be required for the manufacturing site change? A. Comparability data on the two processes must include analytical data and a small clinical trial to prove equivalence. B. Comparability data on the two processes will include analytical data and a nonclinical toxicology study. C. Comparability data on the two processes will include analytical data. D. Comparability is not required as the process is exactly the same.

B. Comparability data on the two processes will include analytical data and a nonclinical toxicology study. Bioanalytical data, stability studies and a nonclinical toxicology study are suggested to prove the two processes are comparable prior to starting the Phase 3 studies at the new manufacturing site.

What type of communication will FDA send an applicant when the review division concludes that an NDA or ANDA cannot be approved in its present form and certain A. Non-approvable letter B. Complete response letter C. Non-approval letter D. Approvable letter

B. Complete response letter All deficiencies identified by FDA will be in the complete response letter. The letter also will reflect the entire review of the application and/or amendments submitted.

What type of communication will FDA send an applicant when the review division concludes that an NDA or ANDA cannot be approved in its present form and certain additional information or clarifications are needed? A. Non-approvable letter B. Complete response letter C. Non-approval letter D. Approvable letter

B. Complete response letter All deficiencies identified by FDA will be in the complete response letter. The letter also will reflect the entire review of the application and/or amendments submitted.

What type of communication will FDA send an applicant when the review division concludes that an NDA or ANDA cannot be approved in its present form and certain additional information or clarifications are needed? A. Non-approvable letter B. Complete response letter C. Non-approval letter D. Approvable letter

B. Complete response letter All deficiencies identified by FDA will be in the complete response letter. The letter also will reflect the entire review of the application and/or amendments submitted.

Good Laboratory Practices Regulations govern the: A. Conduct and control of laboratory activities B. Conduct of nonclinical laboratory studies C. Determination of product efficacy in animals D. Determination of product feasibility

B. Conduct of nonclinical laboratory studies A. The regulation does not cover physical or chemical testing B. 21 CFR 58.3(d) pertains to nonclinical laboratory testing to determine safety C. Testing to determine utility is excluded D. Basic exploratory studies are excluded

Procedures for identifying the control number for each unit, lot or batch of finished devices are required for which type of medical device? A. Surgical gloves B. X-ray machines C. Pacemakers D. Syringes

C. Pacemakers According to 21 CFR 820.65,"Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components." The Pacemaker is a Class III implantable device and subject to 21 CFR 820.65. Sec. 820.65 Traceability. Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

Your company is licensed as a manufacturer of biological IVDs. In order to expand manufacturing capabilities quickly, company management is considering using a contractor to manufacture the active ingredient for one of the IVDs. They have asked you for regulatory advice on the best way to accomplish this while minimizing the impact on the final product labeling and the customer. You recommend: A. Using another manufacturer licensed to manufacture an intermediate product that you then process into the final product B. Contracting with another manufacturer that would manufacture the product under your license C. Participating with another licensed IVD manufacturer that currently manufactures this product and have it perform some of the manufacturing steps D. Entering into a short supply agreement with an unlicensed facility to receive a partially manufactured product

B. Contracting with another manufacturer that would manufacture the product under your license Answer B is the ideal choice as it would represent the least disruption to both your facility and the product labeling since the contractor would be operating under your license. Your license must be amended to include the contract manufacturer and quality/regulatory oversight must be maintained through the quality agreement/contract with the contractor. Under the scenarios in answers A and C, your labeling will have to indicate the new manufacturer. Answer D is not appropriate since short supply agreements are to be used only in specific circumstances not part of this scenario.

In order of highest level to lowest level, the ranking at US governmental organization is: A. Division, Office, Center Agency, Department B. Department, Agency, Center, Office, Division C. Center, Department, Division, Agency, Office D. Agency, Center, Office Department, Division

B. Department, Agency, Center, Office, Division

In order of highest level to lowest level, the ranking at US governmental organizations is: A. Division, Office, Center, Agency, Department B. Department, Agency, Center, Office, Division C. Center, Department, Division, Agency, Office D. Agency, Center, Office, Department, Division

B. Department, Agency, Center, Office, Division

All Class I medical devices are subject to the following requirements EXCEPT: A. Device Master File (DMF) B. Design History File (DHF) C. Device History Record (DHR) D. Medical Device Reporting (MDR)

B. Design History File (DHF) Most Class I devices are not subject to design controls under 21 CFR 820.30 and therefore Design History Files are not required.

Company X is developing marketing materials for a Class II medical device known as "Y". In one marketing piece, the company talks about the clinical data supporting the marketing of the device. Which of the following statements is illegal and should NOT be included int eh marketing materials? A. Company X has conducted clinical studies to demonstrate safety and effectiveness of device Y B. Device Y is approved for marketing in the US C. Warning: Device Y i not compatible with MRI equipment D. Caution: Device Y, when improperly deployed, can cause bleeding

B. Device Y is approved for marketing in the US Class II devices are cleared for marketing in the US by the FDA, not approved. Regulatory Reference: 21 CFR 807.97.

Company X is developing marketing materials for a Class II medical device known as "Y." In one marketing piece, the company talks about the clinical data supporting the marketing of the device. Which of the following statements is illegal and should NOT be included in the marketing materials? A. Company X has conducted clinical studies to demonstrate safety and effectiveness of device Y. B. Device Y is approved for marketing in the US. C. Warning: Device Y is not compatible with MRI equipment. D. Caution: Device Y, when improperly deployed, can cause bleeding.

B. Device Y is approved for marketing in the US. Class II devices are cleared for marketing in the US by FDA, not approved.

Company X is developing marketing materials for a Class II medical device known as "Y." In one marketing piece, the company talks about the clinical data supporting the marketing of the device. Which of the following statements is illegal and should NOT be included in the marketing materials? A. Company X has conducted clinical studies to demonstrate safety and effectiveness of device Y. B. Device Y is approved for marketing in the US. C. Warning: Device Y is not compatible with MRI equipment. D. Caution: Device Y, when improperly deployed, can cause bleeding.

B. Device Y is approved for marketing in the US. Class II devices are cleared for marketing in the US by FDA, not approved.

A drug that has both a high potential for abuse and at least one accepted medical use in the United States is scheduled by which of the following? A. Substance Abuse, Mental Health Services Administration (SAMHSA) B. Drug Enforcement Administration C. National Center for Toxicological Research (NCTR) D. Food and Drug Administration

B. Drug Enforcement Administration A. SAMHSA is responsible for all concerns with substance abuse and mental illness. B. DEA enforces the controlled substance laws and regulations, as they pertain to the manufacturing, distribution and dispensing of legally produced controlled substances. C. NCTR conducts peer reviewed scientific research that supports and anticipates FDA's current and future regulatory needs. D. FDA does not have the statutory authority and does not schedule drugs with abuse liability.

The use of the CTD format is currently mandatory in which of the following countries: EU countries, Japan, Canada, US? A. US and EU countries B. EU countries and Japan C. US only D. It is mandatory in all countries listed

B. EU countries and Japan

Phase 2 clinical trials are being planned for a novel cancer drug. All of the following are appropriate factors in this phase of the study EXCEPT: A. Enrollment of cancer patients B. Enrollment of healthy subjects C. Study of one or more indications D Collection of efficacy data

B. Enrollment of healthy subjects Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study, to determine the common short-term side effects and risks associated with the drug. Phase 2 studies typically are well controlled, closely monitored and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.

Company X is planning to conduct a clinical investigation for its new oral suspension for a reconstituted drug product. What information related to expiration dating is Company X required to include in the investigational drug product labeling? A. New drug products for investigational use are exempt from expiry dating requirements B. Expiration information for the reconstituted drug product is required C. An expiration date assigned on the basis of stability testing of the new drug product is required D. Expiration for the new drug product and reconstituted drug product are both required

B. Expiration information for the reconstituted drug product is required As per FDA regulation, expiration information for the reconstituted new drug product for investigational use is required.

Company X is planning to conduct a clinical investigation for its new oral suspension for a reconstituted drug product. What information related to expiration dating is Company X required to include in the investigational drug product labeling? A. New drug products for investigational use are exempt from expiry dating requirements B. Expiration information for the reconstituted drug product is required C. An expiration date assigned on the basis of stability testing of the new drug product is required D. Expiration for the new drug product and reconstituted drug product are both required

B. Expiration information for the reconstituted drug product is required As per FDA regulation, expiration information for the reconstituted new drug product for investigational use is required.

An important consideration in developing 505(b)(2) products as compared to ANDA products is: A. Lower costs of 505(b)(2) regulated product development and review. B. Extended market exclusivity of 505(b)(2) products. C. Faster FDA processing and approval times for 505(b)(2) products. D. Product development costs and FDA review times for 505(b)(2) products.

B. Extended market exclusivity of 505(b)(2) products. For 505(b)(2) products, there are three to five years of market exclusivity in the US, depending on the extent of changes to the previously approved drug and the amount of data submitted to FDA. This is an apparent advantage when compared to ANDA approval, where exclusivity can be held for only 180 days and applies only to the first generic product. A 505(b)(2) application may itself be granted three years of Waxman-Hatch exclusivity if one or more of the clinical investigations, other than BA/BE studies, was essential to approval of the application and was conducted or sponsored by the applicant (21 CFR 314.50(j); 314.108(b)(4) and (5)). A 505(b)(2) application also be granted five years of exclusivity if it is for a new chemical entity (21 CFR 314.50(j); 314.108(b)(2)). A 505(b)(2) application also may be eligible for orphan drug exclusivity (21 CFR 314.20-316.36) or pediatric exclusivity (section 505A of the act).

An important consideration in developing 505(b)(2) products as compared to ANDA products is: A. Lower costs of 505(b)(2) regulated product development and review. B. Extended market exclusivity of 505(b)(2) products. C. Faster FDA processing and approval times for 505(b)(2) products. D. Product development costs and FDA review times for 505(b)(2) products.

B. Extended market exclusivity of 505(b)(2) products. For 505(b)(2) products, there are three to five years of market exclusivity in the US, depending on the extent of changes to the previously approved drug and the amount of data submitted to FDA. This is an apparent advantage when compared to ANDA approval, where exclusivity can be held for only 180 days and applies only to the first generic product. A 505(b)(2) application may itself be granted three years of Waxman-Hatch exclusivity if one or more of the clinical investigations, other than BA/BE studies, was essential to approval of the application and was conducted or sponsored by the applicant (21 CFR 314.50(j); 314.108(b)(4) and (5)). A 505(b)(2) application also be granted five years of exclusivity if it is for a new chemical entity (21 CFR 314.50(j); 314.108(b)(2)). A 505(b)(2) application also may be eligible for orphan drug exclusivity (21 CFR 314.20- 316.36) or pediatric exclusivity (section 505A of the act).

To avoid the potential for cross-contamination, FDA requires which of the following with regard to the manufacture of penicillin products? A. All human drug products manufactured in a plant where penicillin is also manufactured shall be tested for the presence of penicillin. B. Penicillin products must be manufactured in plants that are inspected quarterly. C. Penicillin products must be manufactured in a facility with a separated air handling system from those used for other drug products for human use. D. Penicillin products must be manufactured under laminar flow protection that is validated periodically.

C. Penicillin products must be manufactured in a facility with a separated air handling system from those used for other drug products for human use. GMP requires dedicated facilities for penicillin manufacture with separate air handling system from other drug products used for human use. See 21 CFR 211.42(d), 211.46(d).

A GCP audit/inspection may include auditing of all of the following EXCEPT: A. Clinical Trial Site(s) B. Data Collection System(s) C. Pre-Clinical Laboratory(s) D. SOPs

C. Pre-Clinical Laboratory(s) A. This is stipulated in the Guidelines for GCP 5.19.3. B. This is stipulated in the Guidelines for GCP 5.19.3. C. This is the correct answer since PreClinical Laboratory(s) are routinely part of a GLP audit/inspection per the Guidelines for GLP. D. This is stipulated in the Guidelines for GCP 5.19.3.

A GMP audit/inspection against the requirements of 21 CFR 2 10/211 may include auditing of all of the following EXCEPT: A. Complaint files B. Qualifications of consultants C. Pre-clinical laboratory(ies) D. SOPs

C. Pre-clinical laboratory(ies) Pre-clinical fall under part 58 not 210/211

A GMP audit/inspection against the requirements of 21 CFR 210/211 may include auditing of all of the following EXCEPT: A. Complaint files B. Qualifications of consultants C. Pre-clinical laboratory(ies) D. SOPs

C. Pre-clinical laboratory(ies) Pre-clinical laboratories are audited under the provisions of Good Laboratory Practices, 21 CFR 58.

Postapproval pharmacovigilance for an adverse drug experience is: A. Mandatory for both manufacturers and healthcare professionals. B. Voluntary for both manufacturers and healthcare professionals. C. Mandatory for manufacturers but voluntary for healthcare professionals. D. Voluntary for manufacturers but mandatory for healthcare professionals.

C. Mandatory for manufacturers but voluntary for healthcare professionals. "(c)(1)(i) The applicant shall report each adverse drug experience that is both serious and unexpected whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the applicant."(iii) The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of postmarketing 15-day Alert reports, shall also apply to any person other than the applicant (nonapplicant) whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor." Sec. 314.80 Postmarketing reporting of adverse drug experiences. (c) Reporting requirements. The applicant shall report to FDA adverse drug experience information, as described in this section. (1)(i) Postmarketing 15-day "Alert reports." The applicant shall report each adverse drug experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the applicant. (ii) Postmarketing 15-day "Alert reports"—follow up. The applicant shall promptly investigate all adverse drug experiences that are the subject of these postmarketing 15-day Alert reports and shall submit follow up reports within 15 calendar days of receipt of new information or as requested by FDA. If additional information is not obtainable, records should be maintained of the unsuccessful steps taken to seek additional information. Postmarketing 15-day Alert reports and follow ups to them shall be submitted under separate cover. (iii) Submission of reports. The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of postmarketing 15-day Alert reports, shall also apply to any person other than the applicant (nonapplicant) whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor. To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of this section, obligations of a nonapplicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a nonapplicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the nonapplicant shall submit each report to the applicant within 5 calendar days of receipt of the report by the nonapplicant, and the applicant shall then comply with the requirements of this section.

A GMP audit/inspection against the requirements of 21 CFR 210/211 may include auditing of all of the following EXCEPT: A. Complaint files. B. Qualifications of consultants. C. Pre-clinical laboratory(ies). D. SOPs.

C. Pre-clinical laboratory(ies).

A GMP audit/inspection against the requirements of 21 CFR 210/211 may include auditing of all of the following EXCEPT: A. Complaint files. B. Qualifications of consultants. C. Pre-clinical laboratory(ies). D. SOPs.

C. Pre-clinical laboratory(ies). Pre-clinical laboratories are audited under the provisions of Good Laboratory Practices, 21 CFR 58.

A manufacturer is closing its current facility for manufacturing an approved drug product. The manufacturer has two other facilities, and has asked regulatory to examine the two locations and develop an appropriate regulatory strategy. Facility A: A large facility being built near the existing facility will have state-of-the-art electronics to monitor the manufacturing process, all new isolated manufacturing areas and all new equipment. The new facility will open one month before the current facility is scheduled to close. This manufacturing process will be the first process moved to this new building. Facility B: A smaller facility 100 miles away from the existing facility has been manufacturing several approved drug products for the same therapeutic purpose for the past 15 years Which is the most accurate analysis/recommendation? A. The transfer of the manufacturing process to Facility A is considered a minor change and will only require a notation of the transfer of the manufacturing process from the current location in the drug product Annual Report. There would be no impact on the manufacturing process or the availability of the drug product. B. Facility A will have a significant positive impact on drug product quality due to the electronic monitoring system and new equipment. The transfer of the manufacturing process to Facility A would be considered a moderate change and could be filed in a CBE 30. C. The transfer of the process to the older Facility B would be considered a major change and would require prior approval from FDA of the change before the drug product could be placed onto the market. D. Facility B has been manufacturing approved drug products for the same therapeutic purpose for the past 15 years and has been inspected by FDA. The move of the manufacturing process to Facility B would be a moderate change and could be filed in a CBE 30.

B. Facility A will have a significant positive impact on drug product quality due to the electronic monitoring system and new equipment. The transfer of the manufacturing process to Facility A would be considered a moderate change and could be filed in a CBE 30. The transfer of a drug product manufacturing process to a new facility requires notification of FDA of the change to the process. In reviewing Facilities A and B, the regulatory professional would recognize that Facility A, although new and state-of-the-art, has not been inspected by FDA and would result in a major change to the approved NDA. This major change would require a prior approval before drug product manufactured in this location could be placed onto the market. Reporting of this manufacturing change in an Annual Report would be incorrect. The transfer of the manufacturing process to Facility B, however, would be a moderate change as FDA has inspected it for the other drug products it currently manufactures. This is considered a moderate change and would result in a Changes Being Effected (CBE) 30 notification to FDA prior to placing the drug product manufactured on the market.

Which of the following is NOT required in a Biologics License Application (BLA) but is required in a New Drug Application (NDA)? A. FDA form 3397 (user fee cover sheet) B. Field copy certification C. Chemistry section D. Debarment certification

B. Field copy certification Field copy certification only applies to NDA products, whereas all of the others sections are requirements for both BLAs and NDAs.

The drug substance manufacturing plant is proposing to widen a critical in-process test limit associated with the final intermediate manufacturing process. What will need to be done in order for the plant to implement the change? A. File the change as an annual reportable change and implement the change immediately B. File a Prior Approval Supplement and wait until agency approval to implement C. This type of change cannot be made to an approved drug substance manufacturing process D. File a Changes Being Effected in 30 days and implement after day 30 if the agency has not contacted the company

B. File a Prior Approval Supplement and wait until agency approval to implement The widening of acceptance criteria for an in process test performed on the final intermediate would be classified as a Prior Approval Supplement. Therefore, the change would need to be filed with and approved by FDA before implementation.

Consent from subjects for clinical study enrollment is a: A. Proposed rule B. Final rule C. Recommendation D. Guideline

B. Final rule The FDA regulation on informed consent became a final rule on 27 January 1981 (21 CFR 50)

The following represent appropriate ways to resolve issues between sponsor and FDA except: A. Advisory Committee meetings B. Following the chain of command C. Role of Ombudsman D. Formal dispute resolution process

B. Following the chain of command

You are the regulatory expert in a small start-up medical device company. A clinical investigation is required for your Class II medical device 510(k) submission. One of the investigators who conducts the study also has received 1,000 stock options from your company as part of his consulting agreement. What information related to this investigator must be included with your 510k submission? A. Form 3454, certifying lack of financial interests and arrangements B. Form 3455, disclosing the stock options for the specific investigator C. Form 3455, disclosing proprietary interest in the tested product D. No additional forms are required

B. Form 3455, disclosing the stock options for the specific investigator The guidance states if the value of stock options cannot be determined through public prices, it needs to be disclosed.

When assembling an New Drug Application, all of the following are required EXCEPT: A. Form FDA 3674 B. Form FDA 2252 C. Form FDA 356h D. Form FDA 3397

B. Form FDA 2252 Form FDA 2252 is required for the Transmittal of Annual Report for Drugs and Biologics for Human Use; see 21 CFR 314.81(2).

At the completion of a Preapproval Inspection where a deficiency was noted, a meeting is convened to discuss what document? A. Form FDA 482 B. Form FDA 483 C. Form FDA 1572 D. EIR

B. Form FDA 483 Form FDA 483 is the most correct as an EIR is not written by FDA until the investigators return to their office. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in his or her judgment may constitute violations of the Food, Drug, and Cosmetic Act (FD&C Act) and related acts. FDA Form 483s are discussed with a company's management at the conclusion of the inspection. Each observation is read and discussed so there is a full understanding of what the observations are and what they mean. EIRs should be completed and submitted for final classification within a timely manner commensurate with the current regulatory action time frames for the anticipated regulatory action, but generally not to exceed 30 working days when no further action is expected. Sec. 20.101 Administrative enforcement records.

A legally marketed device to which equivalence is drawn in a premarketing submission is known as the: A. Comparator device B. Predecessor device C. Predicate device D. Substantially equivalent device

C. Predicate device See 21 CFR 807.92(a)(3) and 21 CFR 807.100(b). 21 CFR 807.92(a)(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process; 21 CFR 807.100(b). The data submitted establishes that the device is substantially equivalent to the predicate device and contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device.

A company has submitted its NDA for review. When must additional safety information be submitted to FDA in a safety update report to avoid triggering an extension of the review clock? A. Six months after the initial NDA submission (180 day safety update) B. Four months after the initial NDA submission (120 day safety update) C. Upon initial NDA submission D. After NDA approval

B. Four months after the initial NDA submission (120 day safety update) "(vi) A summary and updates of safety information, as follows: (b) The applicant shall, under section 505(i) of the act, update periodically its pending application with new safety information learned about the drug that may reasonably affect the statement of contraindications, warnings, precautions, and adverse reactions in the draft labeling. These "safety update reports" are required to include the same kinds of information (from clinical studies, animal studies, and other sources) and are required to be submitted in the same format as the integrated summary in paragraph (d)(5)(vi)(a) of this section. In addition, the reports are required to include the case report forms for each patient who died during a clinical study or who did not complete the study because of an adverse event (unless this requirement is waived). The applicant shall submit these reports (1) 4 months after the initial submission; (2) following receipt of an approvable letter; and (3) at other times as requested by FDA. Prior to the submission of the first such report, applicants are encouraged to consult with FDA regarding further details on its form and content."

The _________ was enacted to deter inappropriate expedition of approval of Abbreviated New Drug Applications A. Hatch-Waxman Act B. Generic Drug Enforcement Act of 1992 C. Kefauver-Harris Drug Amendments D. Food and Drug Administration Modernization Act (FDAMA)

B. Generic Drug Enforcement Act of 1992

Which of the following is NOT TRUE regarding post-approval pharmacovigilance for a drug? A. It is intended to detect all medically important adverse effects and uncommon safety risks in the "real world" of clinical practice. B. Health professionals report all adverse drug reactions associated with the use of a marketed drug. C. Adverse effects from products in the same pharmacologic class as the marketed drug must be considered along with those for the marketed drug. D. Serious and unexpected adverse drug reactions in patients treated outside the United States need to be filed within 15 days after initial notification.

B. Health professionals report all adverse drug reactions associated with the use of a marketed drug. Postmarketing 15-day alert reports are required from the applicant, manufacturer, and any on whose name appears on the label including packer or distributor but not the health professional. See 314.80 (c)(1)(i), 21 CFR 314.80 (c) (1) (iii).

Repeated dose toxicity testing should be performed: A. In two rodent species B. In one rodent and one non-rodent species C. For a minimum of two weeks D. For a minimum of six months

B. In one rodent and one non-rodent species See ICH guideline M3 Maintenance of The ICH Guideline on Non-Clinical Safety Studies for The Conduct of Human Clinical Trials for Pharmaceuticals. Also, the minimum testing time will depend on the duration of the clinical study.

A legally marketed device to which equivalence is drawn in a premarketing submission is known as the: A. Market comparator device. B. Placebo device. C. Predicate device. D. Substantially equivalent device.

C. Predicate device.

A company has been given a product from its British subsidiary to market for the first time in the US. The product is marketed in the EU. A project team gathered by the regulatory practitioner to review the information available for regulatory submission to FDA should: A. Focus on labeling and marketing since mutual recognition does not require complete technical review. B. Include production, marketing, QA, and clinical research for a thorough review C. Summarize financial data and distribution data that is normally required to be submitted to FDA. D. Not be necessary if a Common Technical Document has been prepared by the subsidiary.

B. Include production, marketing, QA, and clinical research for a thorough review A. Mutual recognition has not been finalized between FDA and EMEA, nor would it affect the sponsor's responsibility to assure the accuracy of the submission. B. Correct answer. C. Financial information is not normally submitted to FDA. D. It is the sponsor's responsibility to assure the accuracy of the submission.

A legally marketed device to which equivalence is drawn in a premarketing submission is known as the: A. Market comparator device. B. Placebo device. C. Predicate device. D. Substantially equivalent device.

C. Predicate device. 21 CFR 807.92(a)(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process; 21 CFR 807.100(b). The data submitted establishes that the device is substantially equivalent to the predicate device and contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device.

A company has found a way to produce its drug product more economically; however, the current manufacturing process would have to be changed substantially. What would be the most appropriate post-approval vehicle for this potential action? A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0) B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30) C. Prior approval supplement D. Annual report

C. Prior approval supplemen

A company has found a way to produce its drug product more economically; however, the current manufacturing process would have to be changed substantially. What would be the most appropriate post-approval vehicle for this potential action? A. Post-Approval Supplement: Changes Being Effected - 0 days (CBE 0) B. Post-Approval Supplement: Changes Being Effected - 30 Days (CBE 30) C. Prior approval supplement D. Annual report

C. Prior approval supplement Changes made under this designation are considered to be major, representing a high potential to have an adverse effect on the identity, strength, quality, purity or potency of a drug product. Since the changes to the current manufacturing process are substantial, the potential of the proposed change(s) to adversely affect the identity, strength, quality, purity or potency of the drug product is high and, thus, represent(s) a major change. See FDA's Guidance for Industry: Changes to an Approved NDA or ANDA. See also 21CFR §314.70(b).

A US medical device contract manufacturer has customers for whom it manufactures medical device components (parts) and finished medical devices. To date, all products have been either parts for Class II medical devices or Class II finished medical devices. The manager of new business contacts the regulatory manager to assess the impact of a possible new customer involving a Class III device. What is the first question the regulatory manager should as in order to begin assessing the impact of Class III on plant operpations? A. Is it a sterile device? B. Is it a component or device that would be manufactured? C. Is it an implantable device? D. Is it a single use device?

B. Is it a component or device that would be manufactured? The cited QSR reference states that this regulation is not applicable to component (part) manufacturing; so knowing that it is a component may eliminate QSR compliance. To assess the regulatory impact, one must first know what is to be manufactured at the site, i.e., component or finished device. Many contract device component manufacturers do comply with the QSR; however, in this case, knowing that the new business for a Class III device was to manufacture a component only, would help determine the applicable regulations. For instance, if the job was to manufacture a component only, the need for sterilization may be eliminated because the manufacturer of the finished device may sterilize the component once configured in the finished device. If it were ascertained that the new business was to produce the finished product, the QSR would apply, and possibly other requirements such as 21CFR Part 821 Medical Device Tracking as well. Regulatory Reference: 21CFR 820.1 (a) the Quality System Regulation (QSR).

A company has found a way to produce its drug product more economically; however, the current manufacturing process would have to be changed substantially. What would be the most appropriate post-approval vehicle for this potential action? A. Post-Approval Supplement: Changes Being Effected - 0 days (CBE 0) B. Post-Approval Supplement: Changes Being Effected - 30 Days (CBE 30) C. Prior approval supplement D. Annual report

C. Prior approval supplement Changes made under this designation are considered to be major, representing a high potential to have an adverse effect on the identity, strength, quality, purity or potency of a drug product. Since the changes to the current manufacturing process are substantial, the potential of the proposed change(s) to adversely affect the identity, strength, quality, purity or potency of the drug product is high and, thus, represent(s) a major change. See FDA's Guidance for Industry: Changes to an Approved NDA or ANDA. See also 21CFR §314.70(b).

A company has found a way to produce its drug product more economically; however, the current manufacturing process would have to be changed substantially. What would be the most appropriate post-approval vehicle for this potential action? A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0). B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30). C. Prior approval supplement. D. Annual report.

C. Prior approval supplement.

A US medical device contract manufacturer has customers for whom it manufactures medical device components (parts) and finished medical devices. To date, all medical products produced are either parts for Class II medical devices or are Class II finished medical devices. The manager of new business contacts the regulatory manager to assess the impact of possible new business involving a Class III device. What is the first question the regulatory manager should ask to begin to assess the impact of Class III on plant operations? A. Is it a sterile device? B. Is it a component or finished device that would be manufactured? C. Is it an implantable device? D. Is it a single use device?

B. Is it a component or finished device that would be manufactured? This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Given the QSR is not mandatory to component (part) manufacturing, if the product is a component, this may eliminate QSR compliance. To assess the regulatory impact one must first know what is to be manufactured at the site, i.e., component or finished device. Many contract device component manufacturers do comply with the QSR; however, in this case, knowing the new business for a Class III device was to manufacture a component only would help determine the applicable regulations. For instance, if the job was to manufacture a component, the need for sterilization might be eliminated because the finished device manufacturer might sterilize the component once it is configured in the finished device. If it were ascertained the new business was to produce the finished product, the QSR and possibly other requirements such as 21CFR Part 821 Medical Device Tracking would apply. Applicability of the QSR The QSR applies to finished device manufacturers that intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.

Which of the following is true regarding FDA's MDR program? A. It is not a mandatory program for hospitals. B. It requires the manufacturer to report deaths and serious injuries. C. It does not require the report of serious injury due to malfunction. D. It requires physicians to alert FDA of device malfunctions in their personal practice.

B. It requires the manufacturer to report deaths and serious injuries A. This is required by the MDR regulation. 21 CFR 803.30 B. Tills is the primary requirement of MDR 21 CFR 803.50 C. An MDR does require reporting to FDA of serious injuries resulting from malfunctions. 21 CFR 803.50 D. An MDR does not require physicians to report device malfunctions in their personal practice.

Which of the following is true regarding FDA's MDR program? A. It is not a mandatory program for hospitals B. It requires the manufacturer to report deaths and serious injuries C. It does not require the report of serious injury due to malfunction D. It requires physicians to alert FDA of device malfunctions in their personal practice

B. It requires the manufacturer to report deaths and serious injuries A. This is required by the MDR regulation. 21 CFR 803.30. B. This is the primary requirement of MDR. 21 CFR 803.50. C. An MDR does require reporting to FDA of serious injuries resulting from malfunctions. 21 CFR 803.50 D. An MDR does not require physicians to report device malfunctions in their personal practice.

A drug manufacturer creates a game-based simulation to assist diabetes patients with management of their blood glucose levels and to incentivize them to adhere to their medication schedules. The game will be based on a password protected website that will be made available to patients when an NDA-approved drug is prescribed to them. How will the game most likely be regulated by FDA? A. It should be included as part of the NDA submission B. It will be regulated as a Class I medical device C. It will be regulated as an in vitro diagnostic product D. It will not be an FDA regulated product

B. It will be regulated as a Class I medical device

With regard to NDA applications, all the following are true EXCEPT: A. Labeling and promotional material must be submitted during the preapproval period B. Labeling changes are reported in the quarterly report to an approved NDA C. Fees may be waived if the designated drug is for orphan products D. NDAs may be submitted in the traditional format on paper or electronically

B. Labeling changes are reported in the quarterly report to an approved NDA Depending on the type of change, labeling changes are reported either in the Annual Report or in a supplement. (a) Changes to an approved application. (1)(i) Except as provided in paragraph (a)(1)(ii) of this section, the applicant must notify FDA about each change in each condition established in an approved application beyond the variations already provided for in the application. The notice is required to describe the change fully. Depending on the type of change, the applicant must notify FDA about the change in a supplement under paragraph (b) or (c) of this section or by inclusion of the information in the annual report.

Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records

B. Labeling specifications Labeling specifications are part of the DMR.

A new chemical is introduced into a manufacturing facility. The regulatory affairs practitioner mustensure that which of the following documents are available for the chemical? A. DOT manifest B. MSDS C. Interstate Bill of Lading D. USP monograph

B. MSDS

A new chemical is introduced into a manufacturing facility. The regulatory affairs practitioner must ensure that which of the following documents are available for the chemical? A DOT manifest B. MSDS e. Interstate Bill of Lading D. USP monograph

B. MSDS A This document is not usually required by the manufacturer B. B. The information contained in the MSDS must be disseminated as mandated by OSHA regulations 29 CFR 1900.1200 (Hazard Communication) and various state "employee right to know" laws. Failure to comply may expose the company to legal risk. C. This document is not usually required by the manufacturer. D. This may contain useful information about certain chemicaJs, but there is no statutory mandate that they be available.

A new chemical is introduced into a manufacturing facility. The manufacturer must ensure which of the following documents are available for the chemical? A. DOT manifest B. MSDS C. Interstate Bill of Lading D. USP monograph

B. MSDS A. This document is not usually required by the manufacturer. B. The information contained in the MSDS must be disseminated as mandated by OSHA regulations 29 CFR 1900.1200 (Hazard Communication) and various state "employee right-to-know" laws. Failure to comply may expose the company to legal risk. C. This document is not usually required by the manufacturer. D. This may contain useful information about certain chemicals, but there is no statutory mandate that they be available.

Your company is developing a new drug to be developed and used in combination with a cystoscopic light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is: A. Submit a RFD to FDA OCP for determination of the lead center for primary jurisdiction for the combination product B. Make a preliminary internal company determination of the combination product's PMOA C. Submit an IND along with a RFD to FDA CDER Office of Oncology Drug Products (OODP) D. Submit a RFD to FDA CDRH and notify the OCP

B. Make a preliminary internal company determination of the combination product's PMOA

Your company is developing a new drug to be developed and used in combination with a cystoscopic light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is: A. Submit a Request for Designation to FDA Office of Combination Products for determination of the lead center for primary jurisdiction for the combination product. B. Make a preliminary internal company determination of the combination product's primary mode of action. C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug Products (OODP). D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products.

B. Make a preliminary internal company determination of the combination product's primary mode of action. It is important to determine the primary mode of action first to be able to make a recommendation as to which agency component should have primary jurisdiction, to be followed by a request for designation to FDA OCP if deemed necessary when the classification of a product or the agency center to which it should be assigned in unclear or in dispute.

Which of the following is NOT TRUE regarding judicial enforcement actions? A. FDA may not initiate judicial enforcement action without utilizing the US Court System or the Department of Justice. B. Mandatory product recalls are an example of judicial enforcement. C. Civil money penalties for violation of the Radiation Control for Health and Safety Act are an example of judicial enforcement. D. All judicial enforcement actions are reviewed for legal basis by FDA's Office of Chief Counsel.

B. Mandatory product recalls are an example of judicial enforcement. mandatory recalls are an example of administrative enforcement, not judicial enforcement.

Which of the following is NOT TRUE regarding judicial enforcement actions? A. FDA may not initiate judicial enforcement action without utilizing the US Court System or the Department of Justice. B. Mandatory product recalls are an example of judicial enforcement. C. Civil money penalties for violation of the Radiation Control for Health and Safety Act are an example of judicial enforcement. D. All judicial enforcement actions are reviewed for legal basis by FDA's Office of Chief Counsel.

B. Mandatory product recalls are an example of judicial enforcement. mandatory recalls are an example of administrative enforcement, not judicial enforcement.

MDUFMA authorized 3rd party establishment inspections under carefully prescribed conditions. All the following prescribed conditions about 3rd party establishment inspections are true EXCEPT: A. The establishment must market at least one device in the US and must market a device "in one or more foreign countries." B. Manufactures of class III devices are not eligible for 3rd party inspections. C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI. D. Establishments are required to notify FDA of the person it intends to use and FDA must agree to the selection.

B. Manufactures of class III devices are not eligible for 3rd party inspections. MDUFMA amends section 704 of the FD&C Act to authorize FDA accredited individuals to inspect qualified manufacturers of class II and class III medical devices.

MDUFMA authorized 3rd party establishment inspections under carefully prescribed conditions. All the following prescribed conditions about 3rd party establishment inspections are true EXCEPT: A. The establishment must market at least one device in the US and must market a device "in one or more foreign countries." B. Manufactures of class III devices are not eligible for 3rd party inspections. C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI. D. Establishments are required to notify FDA of the person it intends to use and FDA must agree to the selection.

B. Manufactures of class III devices are not eligible for 3rd party inspections. MDUFMA amends section 704 of the FD&C Act to authorize FDA accredited individuals to inspect qualified manufacturers of class II and class III medical devices.

MDUFMA is an acronym for: A. Managing Department for the Unification of Foreign Medicinal Applications B. Medical Device Users Fee and Modernization Act C. Modernization of Devices Used for Medical Anomalies D. Medical Device Universal Fees for Marketing Applications

B. Medical Device Users Fee and Modernization Act

You recently have been assigned as the regulatory representative for a marketed OTC cough and cold product, regulated by a final monograph. Your product is for adult use only, and contains 0.7% ethanol in the final product. While assessing the product, you notice the alcohol content is not provided on the product labeling. The product is currently out in distribution centers and on store shelves. Your product is in what state and what is the appropriate course of action? A. Adulterated product; voluntary recall to correct the labeling B. Misbranded product; voluntary recall to correct the labeling C. No action is required; as the product is OTC and regulated by a final monograph D. Misbranded product; labeling should be updated immediately to include the alcohol content but no recall of the released product should occur

B. Misbranded product; voluntary recall to correct the labeling The final monograph published in 21 CFR 328 declares that for any product intended for oral ingestion, the ethanol content must be stated on the principal display panel (as defined in 21 CFR 201.60). As the product contains ethanol, but does not carry this statement on the PDP, the product is deemed to be misbranded. In light of several recalls during 2010 related to the PDP labeling of ethanol content, and FDA input on the situation, the voluntary recall is the recommended path forward for this situation.

You are the regulatory representative for a product that is currently available by prescription only and it comes in several different strengths. Due to the nature of the symptoms that the lower dose treats, the drug is considered a candidate for a partial switch as an over-the-counter (OTC) medication. What type of marketing application would you file to support the partial switch of your product? A. New Drug Application Supplement B. NDA C. NDA Deviation D. ANDA

B. NDA (for partial switch) A. New Drug Application Supplement (for full switch)

Premarket Notification is required of manufacturers when introducing which of the following? A. New label size B. New Class II devices C. A change in product name D. Additional manufacturing sites

B. New Class II devices A. This is not considered a significant change in the device. B. This is required for all Class II devices distributed after 28 May 1976. 21 CFR 807.81. C. See explanation A. D. See explanation A.

What type of market exclusivity confers seven years of competition protection from approval of a product application submitted by a market competitor? A. New Chemical Entity (NCE) exclusivity B. Orphan Drug Exclusivity C. Pediatric Exclusivity D. Exclusivity granted for an ANDA with Paragraph IV certification

B. Orphan Drug Exclusivity -Orphan drug exclusivity prevents FDA from approving an application for the same drug for the same condition for seven years. -NCE confers five years of exclusivity (does not apply to ANDA/generics). -Pediatric exclusivity extends all other exclusivity by six months. -Paragraph IV (non-infringement of patent) exclusivity provides 180-day exclusivity to any "first applicant" if all other conditions are met.

If generic drug applicant certifies that the patent applicable to the listed drug has expired, it is a A. Paragraph I certification B. Paragraph II certification C. Paragraph III certification D. Paragraph IV certification

B. Paragraph II certification

MDUFMA authorized 3rd party establishment inspections. All of the following are true about these inspections EXCEPT: A. You need to market at least one device in the United States. B. Participation is mandatory. C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI. D. Establishments are not required to obtain clearance of a 3rd party in advance.

B. Participation is mandatory. B. Per section 201 of MDUFMA, establishments "may" participate. (The Food and Drug Administration (FDA) announced the availability of the guidance entitled ''Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002.'' The Medical Device User Fee and Modernization Act of 2002 authorizes FDA to establish a voluntary inspection program under which manufacturers of class II or class III devices who meet certain eligibility criteria as defined by the statute can elect to have FDA-accredited third parties conduct some of their establishment inspections instead of FDA. Per section 201 of MDUFMA, establishments "may" select an accredited person they are not "required" to do so.

A company has found a way to produce its drug product more economically; however, the current manufacturing process would have to be changed substantially. What would be the most appropriate post-approval vehicle for this potential action? A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0). B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30). C. Prior approval supplement. D. Annual report.

C. Prior approval supplement. Changes made under this designation are considered to be major, representing a high potential to have an adverse effect on the identity, strength, quality, purity or potency of a drug product. Since the changes to the current manufacturing process are substantial, the potential of the proposed change(s) to adversely effect the identity, strength, quality, purity or potency of the drug product is high and, thus, represent(s) a major change. See FDA's "Guidance for Industry Changes to an Approved NDA or ANDA. See also 21CFR §314.70(b).

MDUFMA authorized 3rd party establishment inspections. All of the following are true about these inspections EXCEPT: A. You need to market at least one device in the United States. B. Participation is mandatory. C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI. D. Establishments are not required to obtain clearance of a 3rd party in advance.

B. Participation is mandatory. Per section 201 of MDUFMA, establishments "may" participate. (The Food and Drug Administration (FDA) announced the availability of the guidance entitled ''Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002.'' The Medical Device User Fee and Modernization Act of 2002 authorizes FDA to establish a voluntary inspection program under which manufacturers of class II or class III devices who meet certain eligibility criteria as defined by the statute can elect to have FDA-accredited third parties conduct some of their establishment inspections instead of FDA. Per section 201 of MDUFMA, establishments "may" select an accredited person they are not "required" to do so.

All of the following are considered General Controls under the Food, Drug & Cosmetic Act EXCEPT: A. Establishment registration B. Premarket approval application C. Medical device reporting D. Listing of the device

B. Premarket approval application Premarket approval application (PMA) is not a general control.

All of the following are considered General Controls under the Food, Drug & Cosmetic Act EXCEPT: A. Establishment registration. B. Premarket approval application. C. Medical device reporting. D. Listing of the device.

B. Premarket approval application. PMA is not a general control.

An applicant wants to manufacture an approved tablet at a site that currently produces capsules and has a satisfactory GMP inspection for capsule production. What type of submission would be required for this change? A. Changes Being Affected (CBE) Supplement B. Prior Approval Supplement C. Annual Report D. Supplement New Drug Application

B. Prior Approval Supplement A Prior Approval Supplement is required because the manufacturing process is different. B. Major Changes (Prior Approval Supplement) The following are examples of changes considered to have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. A move to a different manufacturing site for (1) the manufacture, processing, or primary packaging of drug products when the primary packaging components control the dose delivered to the patient or the formulation modifies the rate or extent of availability of the drug, or (2) the manufacture or processing of in-process materials with modified-release characteristics. Examples of these types of drug products include modified-release solid oral dosage forms, transdermal systems, liposomal drug products, depot drug products, oral and nasal metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and nasal spray pumps. Changes that may affect the controlled (or modified) release, metering or other characteristics (e.g., particle size) of the dose delivered to the patient Any fundamental change in the manufacturing process or technology currently used by the applicant.

When the quality of a finished medical device deteriorates over time, each manufacturer shall establish and maintain a product storage and handling system that includes all of the following EXCEPT: A. Separate areas for release and quarantine products. B. Procedures for the control of stock used for shipping supplies. C. Environmentally controlled areas for products with shelf life. D. Procedures for rotation of stock.

B. Procedures for the control of stock used for shipping supplies. here are no storage and handling requirements for shipping supplies. PART 820 -- QUALITY SYSTEM REGULATION Subpart L--Handling, Storage, Distribution, and Installation Sec. 820.150 Storage. (a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate. (b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.

Due to mechanical failure, a product line has remained in process for five days over the time limit established in the company's SOPs. Which of the following should be done first? A. Reject the product since the time limit has been exceeded. B. Proceed with processing and quarantine the product until QA/QC have completed a deviation report and investigation. C. Complete the manufacturing process and ship the product. D. Review the SOP to determine necessity for time limitation.

B. Proceed with processing and quarantine the product until QA/QC have completed a deviation report and investigation. Quarantine would give the company time to conduct an investigation and determine suitability for release. 21 CFR 211.111 and 21 CFR 820.90 describe the requirements for control of nonconforming product, nonconformity review and disposition, etc. for drug product and medical devices respectively.

Due to mechanical failure, a product line has remained in process for five days over the time limit established in the company's SOPs. Which of the following should be done first? A. Reject the product since the time limit has been exceeded. B. Proceed with processing and quarantine the product. C. Complete the manufacturing process and ship the product. D. Have the appropriate department investigate and prepare a deviation report and document all events.

B. Proceed with processing and quarantine the product.

Due to mechanical failure, a product line has remained in process for 5 days over the time limit established in the company's SOPs. The regulatory affairs practitioner should advise the company to do which of the following first? A. Reject the product since the time limit has been exceeded. B. Proceed with processing and quarantine the product. C. Complete the manufacturing process and ship the product. D. Have the appropriate department investigate and prepare a deviation report and document all events.

B. Proceed with processing and quarantine the product. A Exceeding the time limit may not adversely affect the product. B. This would give the company time to conduct an investigation. 21 CFR 211.111, 820.90 C. This might result in an unacceptable product being shipped. D. QC has accept/reject and disposition responsibilities, and any such event must be documented by QC.

Due to mechanical failure, a product line has remained in process for five days over the time limit established in the company's SOPs. Which of the following should be done first? A. Reject the product since the time limit has been exceeded. B. Proceed with processing and quarantine the product. C. Complete the manufacturing process and ship the product. D. Have the appropriate department investigate and prepare a deviation report and document all events.

B. Proceed with processing and quarantine the product. A. Exceeding the time limit may not adversely affect the product. B. This would give the company time to conduct an investigation. 21 CFR 211.111, 820.90. C. This might result in an unacceptable product being shipped. D. QC has accept/reject and dispositioning responsibilities, and any such event must be documented by QC.

Due to mechanical failure, a product line has remained in process for five days over the time limit established in the company's SOPs. Which of the following should be done first? A. Reject the product since the time limit has been exceeded. B. Proceed with processing and quarantine the product. C. Complete the manufacturing process and ship the product. D. Have the Regulatory Affairs department investigate and prepare a deviation report and document all events.

B. Proceed with processing and quarantine the product. This would give the company time to conduct an investigation. 21 CFR 211.111 and 21 CFR 820.90, Nonconforming product, describes the requirements for control of non conforming product, nonconformity review and disposition, etc. for medical devices.

Which of the following are NOT required to be included in a Request for Designation (RFD) for a combination product? A. The product's proprietary name B. Process validation protocols and reports C. Chemical, physical or biological composition D. The sponsor's identity

B. Process validation protocols and reports Process validation protocols and reports are not required to be submitted as part of the RFD.

Which of the following is not required in a RFD for a combination product? A. The product's proprietary name B. Process validation protocols and reports C. Chemical, physical or biological composition D. The sponsor's identity

B. Process validation protocols and reports RFD: Request for designation

In the development of a revised manufacturing procedure, which of the following is a critical step in ensuring that the product manufactured would not be adversely affected by the change? A. Procedure qualification B. Product verification and/or process validation C. Quality control D. Conformance inspection

B. Product verification and/or process validation This ensures that the product has not been adversely affected.

In the development of a revised manufacturing procedure, which of the following is a critical step in ensuring that the product manufactured would not be adversely affected by this change? A. Procedure qualification B. Product verification and/or process validation C. Quality control D. Conformance inspection

B. Product verification and/or process validation A. Merely qualifying one procedure does not necessarily assure that the remainder of the product is not adversely affected. B. This ensures that the product has not been adversely affected. C. This alone does not ensure that the product has not been adversely affected. D. This does not ensure the quality of the final product.

In the development of a revised manufacturing procedure, which of the following is a critical step in ensuring that the product manufactured would not be adversely affected by this change? A. Procedure qualification. B. Product verification and/or process validation. C. Quality control. D. Conformance inspection.

B. Product verification and/or process validation. This ensures that the product has not been adversely affected.

FDA's office of Generic Drugs (OGD) remains committed to the "first-in, first-reviewed" review order for the reviewing original Abbreviated New Drug Application (ANDAs), amendments and supplements unless there is a specific reason to expedite an application. Which of the following is NOT specific reason to grant expedited review? A. Products to respond to current and anticipated health emergencies B. Products that show evidence of safety and effectiveness in a new subpopulation C. Products for which a nationwide shortage has been identified D. First generic products for which there is no blocking patents or exclusivities on the Reference Listed Drug (RLD)

B. Products that show evidence of safety and effectiveness in a new subpopulation

All of the following are additional IND submissions to FDA EXCEPT: A. Information Amendments B. Protocol Deviations C. IND Safety Reports D. Annual Reports

B. Protocol Deviations B. Protocol Deviations need to be reported to the sponsor and are reported to the IRB, per their individual guidelines.

All of the following are additional IND submissions to FDA EXCEPT: A. Information amendments. B. Protocol deviations. C. IND safety reports. D. Annual reports.

B. Protocol deviations.

All of the following are additional IND submissions to FDA EXCEPT: A. Information amendments. B. Protocol deviations. C. IND safety reports. D. Annual reports.

B. Protocol deviations. Protocol deviations are departures from the specific procedure as described in the protocol or protocol amendment without prior IRB approval. They need to be reported to the sponsor and are reported to the IRB, per their individual guidelines.

When requesting a meeting to discuss a proposed clinical study with FDA, the regulatory affairs practitioner will usually be asked to do which of the following? A. Schedule the meeting through a congressman. B. Provide FDA an agenda and information package prior to the meeting. C. Bring a secretary to transcribe the discussion. D. Bring no more than four individuals.

B. Provide FDA an agenda and information package prior to the meeting. A This will cause a negative reaction and put FDA negotiations on the defensive. B. Procedural guidelines require that a manufacturer provide FDA with an agenda of the items to be discussed. C. This may be perceived by FDA as being similar to a deposition and they may not be willing to discuss issues as freely. D. FDA may occasionally limit the number of individuals attending the meeting.

When requesting a meeting to discuss a proposed clinical study with FDA, the regulatory affairs practitioner will usually be asked to do which of the following? A. Schedule the meeting through a congressman B. Provide FDA an agenda and information package prior to the meeting C. Bring a secretary to transcribe the discussion D. Bring no more than four individuals

B. Provide FDA an agenda and information package prior to the meeting A. This will cause a negative reaction and put FDA negotiations on the defensive. B. Procedural guidelines require that a manufacturer provide FDA with an agenda of the items to be discussed. C. This may be perceived by FDA as being similar to a deposition and they may not be willing to discuss issues as freely. D. FDA may occasionally limit the number of individuals attending the meeting.

Disease awareness or "help-seeking" communications may: A. Not be disseminated directly to consumers B. Provide health care practitioners with information to assist in the diagnosis of a particular disease C. Mention a specific drug by the established name only D. Not be combined with Reminder advertising

B. Provide health care practitioners with information to assist in the diagnosis of a particular disease Disease awareness communications may, if aimed at healthcare practitioners, encourage awareness of signs of the particular disease or health condition, or otherwise provide information to assist in the diagnosis of the particular disease or health condition.

Disease awareness or "help-seeking" communications may: A. Not be disseminated directly to consumers B. Provide health care practitioners with information to assist in the diagnosis of a particular disease C. Mention a specific drug by the established name only D. Not be combined with Reminder advertising

B. Provide health care practitioners with information to assist in the diagnosis of a particular disease Disease awareness communications may, if aimed at healthcare practitioners, encourage awareness of signs of the particular disease or health condition, or otherwise provide information to assist in the diagnosis of the particular disease or health condition.

For which of the following records is 21 CFR Part 11 NOT applicable? A. Records in electronic format in lieu of paper format which are required to be maintained under predicate rule B. Records in electronic format in lieu of paper format which are not required to be maintained under predicate rule C. Records in electronic format in addition to paper format which are required to be maintained under predicate rule D. Electronic records that a

B. Records in electronic format in lieu of paper format which are not required to be maintained under predicate rule Part 11 is not applicable to electronic records not required under predicate rules as per FDA Final Guidance August 2003.

For which of the following records is 21 CFR Part 11 NOT applicable? A. Records in electronic format in lieu of paper format which are required to be maintained under predicate rule B. Records in electronic format in lieu of paper format which are not required to be maintained under predicate rule C. Records in electronic format in addition to paper format which are required to be maintained under predicate rule D. Electronic records that are intended to be the equivalent of handwritten signatures required by predicate rules

B. Records in electronic format in lieu of paper format which are not required to be maintained under predicate rule Part 11 is not applicable to electronic records not required under predicate rules as per FDA Final Guidance August 2003.

The following applies to autologous chondrocytes expanded in vitro for the repair of cartilage defects: A. Regulated under Section 351 of the Public Health Service Act and no premarket approval required B. Regulated under Section 351 of the Public Health Service Act and premarket approval required C. Regulated under Section 361 of the Public Health Service Act and no premarket approval required D. Regulated under Section 361 of the Public Health Service Act and premarket approval required

B. Regulated under Section 351 of the Public Health Service Act and premarket approval required The product is a HCT/P (human cells, tissues and cellular and tissue-based products). In vitro expansion of cells is considered more than minimal manipulation. The product therefore does not meet the criteria to be subject to regulation under section 361 of the PHS Act (criteria: minimal manipulation; homologous use; not combined with another article; no systemic effect and not dependent on metabolic activity of living cells except if for autologous use, use in a first-degree or second-degree blood relative or for reproductive use) and is regulated under section 351 of the PHS Act and requires a Biologics License Application (BLA).

The following applies to autologous chondrocytes expanded in vitro for the repair of cartilage defects: A. Regulated under Section 351 of the Public Health Service Act and no premarket approval required B. Regulated under Section 351 of the Public Health Service Act and premarket approval required C. Regulated under Section 361 of the Public Health Service Act and no premarket approval required D. Regulated under Section 361 of the Public Health Service Act and premarket approval required

B. Regulated under Section 351 of the Public Health Service Act and premarket approval required The product is a HCT/P (human cells, tissues and cellular and tissue-based products). In vitro expansion of cells is considered more than minimal manipulation. The product therefore does not meet the criteria to be subject to regulation under section 361 of the PHS Act (criteria: minimal manipulation; homologous use; not combined with another article; no systemic effect and not dependent on metabolic activity of living cells except if for autologous use, use in a first-degree or second-degree blood relative or for reproductive use) and is regulated under section 351 of the PHS Act and requires a Biologics License Application (BLA).

A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should: A. Write a letter to FDA requesting a Type A meeting as an amendment to the IND B. Request a Type B meeting as an amendment to the IND C. Call the project manager and set up a date over the phone for a Type C meeting D. Email the division director with a list of three dates, 30 days into the future

B. Request a Type B meeting as an amendment to the IND See the CDER/CBER guidance published in February 2000 entitled Formal Meetings With Sponsors and Applicants for PDUFA Products.

A regulatory affairs professional wants to schedule a pre-NDA meeting with the FDA. He or she should: A. Write a letter to the FDA. B. Request a Type B meeting as an amendment to the IND. C. Call the project manager and set up a date over the phone. D. Email the division director with a list of three dates, 30 days into the future.

B. Request a Type B meeting as an amendment to the IND. See the CDER/CBER guidance published in February 2000 entitled "Formal Meetings With Sponsors and Applicants for PDUFA Products".

A US medical device company wants to sell a Class III product in Australia, where it has recently obtained approval. However, this product does not currently have approval in the US. The product is manufactured in accordance with US Quality System Regulations. Which is the appropriate regulatory action in the US before the product can be exported to Australia? A. Obtain an export permit from FDA as per 801(e)(2). B. Send a simple notification to FDA and obtain an 802 Certificate of Exportability from FDA (if requested by Australia). C. Wait for product approval in the US before exporting to Australia. D. No action is required. The product can be shipped to Australia without US FDA notification or approval.

B. Send a simple notification to FDA and obtain an 802 Certificate of Exportability from FDA (if requested by Australia). US export regulations require a simple notification to FDA if a Class III product without US approval is approved for sale in a Tier I country (including Australia). The 802 Certificate of Exportability can be obtained from FDA if the foreign country requests written assurance that the product complies with US law, but this is not a US requirement to export. The 1996 FDA Export Reform amendments to the FD&C Act provided for FDA to issue certificates for exports of certain products even though the products are not allowed to be marketed in the US. FDA issues Certificates of Exportability for biologics, animal drugs and devices that may be exported under these provisions of the act but may not otherwise be marketed, sold, offered for sale or distributed in the US. Exporting Medical Devices Via Section 801(e)(1) Requirements A medical device which would be considered to be adulterated or misbranded, may be exported under Section 801(e)(1) of the FD&C Act provided the device is intended solely for export. Although such a device would not meet the requirements of the FD&C Act to be sold domestically for commercial distribution, it may be exported legally and without FDA permission in accord with Section 801(e)(1) provided the device is: -in accordance with the specifications of the foreign purchaser; -not in conflict with the laws of the country to which it is intended for export; -labeled on the outside of the shipping package that it is intended for export; and -not sold or offered for sale in domestic commerce.

Which of the following is considered part of the Device Mater Record? A. Employee training record B. Serial number label C. Design reviews D. Calibration records

B. Serial number label Labeling specifications are part of the DMR. Regulatory Reference: 21 CFR 820.181(d).

A company decides to add an additional quality control test during in-process testing of its marketed Class III device. The appropriate submission to send to FDA for this change is: A. 180 Day PMA Supplement B. Special PMA Supplement—Changes Being Effected C. 30-Day Notice D. Annual Report

B. Special PMA Supplement—Changes Being Effected The Special PMA Supplement is used when the change enhances or increases the device's safety.

A medical device that has not been released for sale or use is shipped to a foreign distributor of Company XYZ. Company XYZ contacts the foreign distributor and the foreign distributor confirms the product is still at its warehouse in the US. Company XYZ requests the foreign distributor to return the medical device immediately. The enforcement activity described is an example of a: A. Market Withdrawal B. Stock Recovery C. Class I Recall D. Class III Recall

B. Stock Recovery The product has not been marketed, has not been released for sale or use and is located on premises under the control of the manufacturer's foreign distributor. Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the firm's direct control, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.

A drug company's Phase 3 trials will conclude in six months. Members of the statistics team have questions pertaining to the pooling of studies for the statistical analysis in eCTD Module 2. As the regulatory professional, what is the best course of action: A. Submit a meeting request to FDA for a Type A meeting B. Submit a meeting request to FDA for a Type B meeting C. Submit a meeting request to FDA for a Type C meeting D. Submit a Special Protocol Assessment to review the statistical analysis plan

B. Submit a meeting request to FDA for a Type B meeting Type B meetings include Pre-NDA meetings. A Pre-NDA meeting can be used to discuss appropriate methods for statistical analysis of data in the marketing application.

A drug company's Phase 3 trials will conclude in six months. Members of the statistics team have questions pertaining to the pooling of studies for the statistical analysis in eCTD Module 2. As the regulatory professional, what is the best course of action: A. Submit a meeting request to FDA for a Type A meeting B. Submit a meeting request to FDA for a Type B meeting C. Submit a meeting request to FDA for a Type C meeting D. Submit a Special Protocol Assessment to review the statistical analysis plan

B. Submit a meeting request to FDA for a Type B meeting Type B meetings include Pre-NDA meetings. A Pre-NDA meeting can be used to discuss appropriate methods for statistical analysis of data in the marketing application.

A drug company's Phase 3 trials will conclude in six months. Members of the statistics team have questions pertaining to the pooling of studies for the statistical analysis in eCTD Module 2. As the regulatory professional, what is the best course of action: A. Submit a meeting request to FDA for a Type A meeting B. Submit a meeting request to FDA for a Type B meeting C.Submit a meeting request to FDA for a Type C meeting D.Submit a Special Protocol Assessment to review the statistical analysis plan

B. Submit a meeting request to FDA for a Type B meeting Type B meetings include Pre-NDA meetings. A Pre-NDA meeting can be used to discuss appropriate methods for statistical analysis of data in the marketing application.

A pharmaceutical company decides to collaborate with a diagnostic device manufacturer in the development of a new therapeutic drug. The diagnostic device is intended to identify patients who are most likely to benefit from use of the therapeutic product. The device previously has been cleared for a different intended use. What should the diagnostic device manufacturer do prior to commercial distribution of the device for the new intended use? A. Define the patient population identified by the diagnostic device B. Submit a new premarket submission for the device for use with the novel therapeutic product C. Revise the labeling to specify the therapeutic product which the device has been approved or cleared for use D. Identify the therapeutic class of products in which the diagnostic device may be applicable for use

B. Submit a new premarket submission for the device for use with the novel therapeutic product The best choice is B. A and C alone are not sufficient to legally market a device. A therapeutic class, instead of a specific therapeutic product, should not be claimed unless there is sufficient evidence to support this.

Which of the following subsystems is NOT required by FDA in order to implement and maintain a Quality System? A. Production and process controls B. Test and control article characterization C. Packaging and labeling controls D. Facility and equipment controls

B. Test and control article characterization This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical Laboratory Studies, not by quality system or GMP requirements. Note that Laboratory controls for finished pharmaceuticals are required by 21CFR 211, Subpart I.

Which of the following subsystems is NOT required by FDA in order to implement and maintain a Quality System? A. Production and process controls. B. Test and control article characterization. C. Packaging and labeling controls. D. Buildings and facilities.

B. Test and control article characterization. This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical Laboratory Studies, not by quality system or GMP requirements. Note that Laboratory controls for finished pharmaceuticals are required by 21CFR 211, Subpart I.

Following the "elixir of Sulfanilamide" tragedy, public outcry led to the 1938 passage of A. The Pure Food and Drug Act B. The Federal Food Drug and Cosmetic Act C. The Kefauver-Harris Drug Amendments D. The Public Health Service Act

B. The Federal Food Drug and Cosmetic Act

Following the "elixir of Sulfanilomide" tragedy, public outcry led to the 1938 passage of: A. The Pure Food and Drug Act B. The Federal Food Drug and Cosmetic Act C. The Kefauver-Harris Drug Amendments D. The Public Health Service Act

B. The Federal Food Drug and Cosmetic Act

A pharmaceutical firm filed an ANDA for a generic version of an approved drug under paragraph IV certification. The original NDA holder then filed suit against the generic drug firm. All of the following statements are true with respect to paragraph IV certification and subsequent legal challenge EXCEPT: A. A stay provision is automatically triggered so that the ANDA will not be approved for 30 months B. The NDA holder does not need to show any likelihood of success on the merits of the suit C. Multiple and overlapping 30-month stays can be imposed with respect to each ANDA D. The 30-month period will expire if a court issues a final order determining that the patent is invalid, unenforceable, or not infringed

B. The NDA holder does not need to show any likelihood of success on the merits of the suit A. 21 CFR 314.107(b)(3)(i)(A) B. This is in contrast to the requirements for issuance of a preliminary injunction, where likelihood of success and irreparable harm must be demonstrated. C. Under FDA's traditional interpretation, multiple and overlapping 30-month stays could be imposed. However, in a Final Rule, a maximum of one 30-month stay per ANDA may be allowed. See FDA "Application for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed." June 18, 2003. D. 21 CFR 314.107(b)(3)(i)(B)(ii)

A removal of a distributed product involved in a minor violation that would be subject to legal action by FDA is known as: A. Stock recovery B. Market withdrawal C. Product recall D. Corrective action

C. Product recall Market withdrawal is not subject to legal action by FDA. (k) Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use. (j) Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs (g) Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

FDA has conducted an initial review of your company's PMA application and issued a set of deficiencies. A PMA amendment has been submitted to FDA in response to the deficiencies. In the meantime, FDA has requested a Panel Meeting for review of the PMA. Your company has begun preparing for the Panel Meeting. Six weeks prior to the scheduled Panel Meeting, FDA issues a letter stating the PMA is now not approvable because additional deficiencies have been identified and some of the responses to the previous deficiencies are not adequate. As the regulatory person responsible for this submission, you will direct the project team as follows: A. The Panel Meeting will occur as scheduled, so prepare for the meeting and at a later date respond to the recent deficiencies B. The Panel Meeting will be postponed until FDA receives adequate responses to the deficiencies; focus all efforts on responses to the deficiencies C. There will be no future Panel Meeting; focus all efforts on responses to the deficiencies D. Prepare for the scheduled Panel Meeting and plan to address the deficiencies at the meeting

B. The Panel Meeting will be postponed until FDA receives adequate responses to the deficiencies; focus all efforts on responses to the deficiencies The Panel Meeting would not take place as scheduled because the PMA is considered nonapprovable until the deficiencies are addressed. The company has 180 days to submit an amendment to the PMA and a Panel Meeting would be rescheduled for a later date pending the company's responses to the deficiencies.

FDA has conducted an initial review of your company's PMA application and issued a set of deficiencies. A PMA amendment has been submitted to FDA in response to the deficiencies. In the meantime, FDA has requested a Panel Meeting for review of the PMA. Your company has begun preparing for the Panel Meeting. Six weeks prior to the scheduled Panel Meeting, FDA issues a letter stating the PMA is now not approvable because additional deficiencies have been identified and some of the responses to the previous deficiencies are not adequate. As the regulatory person responsible for this submission, you will direct the project team as follows: A. The Panel Meeting will occur as scheduled, so prepare for the meeting and at a later date respond to the recent deficiencies B. The Panel Meeting will be postponed until FDA receives adequate responses to the deficiencies; focus all efforts on responses to the deficiencies C. There will be no future Panel Meeting; focus all efforts on responses to the deficiencies D. Prepare for the scheduled Panel Meeting and plan to address the deficiencies at the meeting

B. The Panel Meeting will be postponed until FDA receives adequate responses to the deficiencies; focus all efforts on responses to the deficiencies The Panel Meeting would not take place as scheduled because the PMA is considered nonapprovable until the deficiencies are addressed. The company has 180 days to submit an amendment to the PMA and a Panel Meeting would be rescheduled for a later date pending the company's responses to the deficiencies.

FDA has conducted an initial review of your company's Premarket Approval Application (PMA) and issued a set of deficiencies. A PMA amendment has been submitted to FDA in response to the deficiencies. In the meantime. FDA has requested a Panel meeting for review of the PMA. Your company has begun preparing for the Panel meeting. Six weeks prior to the scheduled Panel meeting. FDA issues a letter stating that the PMA is no not approvable because additional deficiencies have been identified und some of the responses to the previous deficiencies are not adequate. As the regulatory person responsible for this submission, you will direct the project team as follows: A. The Panel meeting will occur as scheduled, so prepare for the meeting and at later date respond to tbc recent deficiencies B. The Panel meeting will be postponed until FDA receives adequate responses to the deficiencies; focus all efforts on responses to the deficiencies C. There will be no future panel meeting; focus all efforts on responses to the deficiencies D. Prepare for the scheduled Panel meeting and plan to address the deficiencies at the Panel meeting

B. The Panel meeting will be postponed until FDA receives adequate responses to the deficiencies; focus all efforts on responses to the deficiencies

Six months after FDA approval of drug "X," your company wishes to make the following labeling changes to the PI: (1) Addition of an adverse event due to information reported to the agency; and (2) Expansion of population based on data. Which of the following represents both an accurate statement AND an appropriate regulatory strategy for submission of these changes? A. The addition of adverse event information and the expansion of population are both major changes. Submit these changes together in a Prior Approval Supplement (PAS). B. The addition of adverse event information is a moderate change while expansion of population is a major change. Submit these changes together in a PAS. C. Both of the proposed changes are moderate changes. Submit these changes together as a Changes Being Effected Supplement (CBE). D. The addition of adverse event information is a moderate change, while expansion of population is a major change. Changes with differing reporting categories cannot be submitted simultaneously. Submit a CBE and PAS separately

B. The addition of adverse event information is a moderate change while expansion of population is a major change. Submit these changes together in a PAS. The addition of adverse event information is considered a moderate change, which by itself would be submitted as a CBE. The expansion of population is considered a major change, which by itself would be considered as a PAS. For multiple related changes where the recommended reporting categories for the individual changes differ, CDER recommends that the submission be in accordance with the most restrictive of the categories recommended for the individual changes. Therefore, these changes should be submitted together in a Prior Approval Supplement.

Six months after FDA approval of drug "X," your company wishes to make the following labeling changes to the PI: (1) Addition of an adverse event due to information reported to the agency; and (2) Expansion of population based on data. Which of the following represents both an accurate statement AND an appropriate regulatory strategy for submission of these changes? A. The addition of adverse event information and the expansion of population are both major changes. Submit these changes together in a Prior Approval Supplement (PAS). B. The addition of adverse event information is a moderate change while expansion of population is a major change. Submit these changes together in a PAS. C. Both of the proposed changes are moderate changes. Submit these changes together as a Changes Being Effected Supplement (CBE). D. The addition of adverse event information is a moderate change, while expansion of population is a major change. Changes with differing reporting categories cannot be submitted simultaneously. Submit a CBE and PAS separately

B. The addition of adverse event information is a moderate change while expansion of population is a major change. Submit these changes together in a PAS. The addition of adverse event information is considered a moderate change, which by itself would be submitted as a CBE. The expansion of population is considered a major change, which by itself would be considered as a PAS. For multiple related changes where the recommended reporting categories for the individual changes differ, CDER recommends that the submission be in accordance with the most restrictive of the categories recommended for the individual changes. Therefore, these changes should be submitted together in a Prior Approval Supplement.

Which of the following is NOT TRUE for an FDA inspection of a facility that manufactures a small molecule drug? A. A notice of inspection (FDA 482 form) is presented by the FDA investigator on arrival at the facility. B. The credentials of the FDA investigator can be photocopied for filing at the facility. C. The FDA investigator provides inspectional findings on a FDA 483 form. D. The FDA investigator provides an FDA 484 form to describe samples taken during the inspection.

B. The credentials of the FDA investigator can be photocopied for filing at the facility. Federal Law (Title 18, U.S.C. 701) prohibits photographing, counterfeiting or misuse of official credentials.

A removal of a distributed product involved in a minor violation that would be subject to legal action by FDA is known as: A. Stock recovery B. Market withdrawal C. Product recall D. Corrective action

C. Product recall Market withdrawal is not subject to legal action by FDA. PART 7 -- ENFORCEMENT POLICY Subpart A--General Provisions Sec. 7.3 Definitions. (k) Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use. (j) Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. (g) Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

All of the following are types of regulatory inspections for a pharmaceutical product EXCEPT: A. Preapproval inspection (PAI) for a drug application B. For cause audit C. QSR audit D. GMP audit

C. QSR audit QSR audits are performed for medical devices.

A company is evaluating next steps for a small Phase 1/2 clinical trial. There are four cohorts and the company has just completed enrollment of the third cohort. Efficacy data from immunology testing have revealed a small signal was detected. Based on these data; the company believes the fourth cohort should be dosed with a higher concentration of drug product. The concentration required is higher than the current dose of the drug product and may not be supported nonclinical toxicology studies. The higher dose also will require some additional product development and the time to manufacture is estimated to be approximately 18 months. What is the best regulatory approach? A. Recruitment on the current clinical protocol should be put on hold for two years to wait for the new drug product. B. The current clinical protocol should be terminated and a new clinical protocol written with the new dosing supported by nonclinical studies. C. The clinical protocol should be amended and increased dosing schedule be incorporated into the protocol. D. The clinical protocol should be amended and the dosing of the current drug product increased.

B. The current clinical protocol should be terminated and a new clinical protocol written with the new dosing supported by nonclinical studies. Trials that are inactive for two years are put on FDA inactive list

Drug X is already approved for the treatment of blood cancer in the US. The manufacturer plans to submit an NDA for the same drug to treat condition ABC, which affects 50,000 women in the US. You are asked to consider whether this new NDA can be submitted under Orphan Drug Designation (ODD)? What will be your recommendation regarding ODD status? A. The manufacturer can request an Orphan Drug Designation (ODD) since condition ABC affects 50,000 women in the US B. The drug would be eligible for orphan status since it is a new orphan indication from the already approved indication of blood cancer C. The manufacturer can request ODD for condition ABC and for the blood cancer use D. The drug can request ODD after setting up a meeting with FDA's Office of Orphan Product Development (OOPD)

B. The drug would be eligible for orphan status since it is a new orphan indication from the already approved indication of blood cancer

In conformance with GMP, which of the following departments is responsible for approving or rejecting finished pharmaceuticals? A. Regulatory affairs. B. Quarantine and inspection. C. Quality control. D. Operations.

C. Quality control QC has the responsibility and authority to approve or reject final products, 21 CFR 211.22. Establishment of a Quality system is a requirement for QSR, 21 CFR 820.5, 820.20, 820.22, 820.80. Additional information is available in Medical Device Quality Systems Manual: A Small Entity Compliance Guide. GTPs also mandate establishment of a Quality Program, 21 CFR 1271.160.

Drug X is already approved for the treatment of blood cancer in the US. The manufacturer plans to submit a New Drug Application (NDA) for the same drug to treat a new indication, which affects 50,000 women in the US. You are asked to consider whether this new NDA can be submitted under Orphan Drug Designation (ODD). What will be your recommendation regarding ODD status? A. The manufacturer can request an ODD since blood cancer affects 50,000 women in the US B. The drug would be eligible for orphan status since it is a new orphan indication from the already approved indication of blood cancer C. The manufacturer can request ODD for the new indication and for the blood cancer use D.The drug manufacturer can request ODD after setting up a meeting with FDA's Office of Orphan Product development (OOPD)

B. The drug would be eligible for orphan status since it is a new orphan indication from the already approved indication of blood cancer A sponsor may request orphan drug designation of a previously unapproved drug or of a new orphan indication for an already marketed drug. One of the conditions for a drug product to be eligible for orphan status is that the drug should not be the subject of a marketing application submitted prior to filing an orphan status request. FILE BEFORE NDA

In conformance with GMP, which of the following departments is responsible for approving components used in the manufacturing of finished pharmaceuticals? A. Regulatory affairs. B. Quarantine and inspection. C. Quality control. D. Operations.

C. Quality control. QC has the responsibility and authority to approve components for the manufacture of pharmaceuticals, 21 CFR 211.84(a).

After product approval, ADE's that do not meet the 15-day reporting requirements should be reported by the company: A. Bi-annually, unless alternative reporting is required by FDA. B. Annually, unless alternative reporting is required by FDA. C. Quarterly for three years after application approval, annually thereafter, unless alternative reporting is required by FDA. D. Quarterly for two years after application approval, annually thereafter, unless alternative reporting is required by FDA.

C. Quarterly for three years after application approval, annually thereafter, unless alternative reporting is required by FDA. ADEs should be reported quarterly for the first three years and annually thereafter. Sec. 314.80 Postmarketing reporting of adverse drug experiences. (2) Periodic adverse drug experience reports. (i) The applicant shall report each adverse drug experience not reported under paragraph (c)(1)(i) of this section at quarterly intervals, for 3 years from the date of approval of the application, and then at annual intervals.

A shampoo that contains an ingredient that prevents dandruff is being distributed by your company, from a foreign manufacturer. The product will be available at retail establishments. Which of the following is required for the product labeling? A. The established name of each inactive ingredient must be listed in alphabetical order. B. The established name of each inactive ingredient must be listed in order of predominance in the formulation along with the name and address of the foreign manufacturer or distributor. C. A tamper evidence statement included in the "Other information" section of the Drug Facts section. D. The name and address of the US manufacturer or distributor

B. The established name of each inactive ingredient must be listed in order of predominance in the formulation along with the name and address of the foreign manufacturer or distributor. A shampoo is a cosmetic because its intended use is to cleanse the hair but an anti-dandruff treatment is a drug. The product must comply with the requirements for both cosmetics and drugs. The drug ingredients must be listed alphabetically as "Active Ingredients," followed by "inactive ingredients," listed in descending order of predominance. Although a tamper evidence statement is required, it does not have to be in the "Other Information" section of the Drug Facts box. The US company in this scenario is a distributor and would not be listed as the manufacturer.

When the proprietary name or designation is used in promotion, the following is TRUE: A. The proprietary name or designation can, in certain instances, be used without the accompaniment of the established name. B. The established name shall be printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined. C. The established name shall be printed in letters that are at least 1⁄4 as large as the letters compromising the proprietary name or designation. D. The proprietary name or designation must be printed in letters at least twice as large as the established name.

B. The established name shall be printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined. This is true under 21 CFR 202.1(b)(2)

Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE? A. An investigator shall report to the sponsor within 5 working days a withdrawal of approval by the IRB. B. The investigator shall report device use without obtaining informed consent to the sponsor and the reviewing IRB within 10 working days after the use occurs. C. The sponsor shall notify FDA within 30 working days of the completion or termination of an investigation for a significant risk device. D. An investigator shall submit to the sponsor and IRB a report of any unanticipated adverse device effect within 10 working days after the investigator first learns of the effect.

B. The investigator shall report device use without obtaining informed consent to the sponsor and the reviewing IRB within 10 working days after the use occurs. The investigator shall report device use without obtaining informed consent to the sponsor and the reviewing IRB within 5 working days after the use occurs. See 21 CFR 812.150(a)(5).

26. Your company recently submitted a Biologics License Application (BLA) to CDER and the review division has notified you that you must develop and submit a Medication Guide. This request may have resulted from any of the following EXCEPT: A. The product is once for which patient labeling could help prevent serous adverse effects B. The product is one that has been demonstrated though adequate and well-controlled trials to be less effective than alternative therapies C. The product is one that has serious risks relative to benefits that must be communicated to the patients D. The product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness

B. The product is one that has been demonstrated though adequate and well-controlled trials to be less effective than alternative therapies

Postapproval pharmacovigilance for an adverse drug experience is: A. Mandatory for both manufacturers and healthcare professionals. B. Voluntary for both manufacturers and healthcare professionals. C. Mandatory for manufacturers but voluntary for healthcare professionals. D. Voluntary for manufacturers but mandatory for healthcare professionals.

C. Mandatory for manufacturers but voluntary for healthcare professionals. 21 CFR 314.80 (c)(1)(i) and (iii) MedWatch Form FDA 3500 and 3500A "(c)(1)(i) The applicant shall report each adverse drug experience that is both serious and unexpected whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the applicant."(iii) The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of postmarketing 15-day Alert reports, shall also apply to any person other than the applicant (nonapplicant) whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor." Sec. 314.80 Postmarketing reporting of adverse drug experiences. (c) Reporting requirements. The applicant shall report to FDA adverse drug experience information, as described in this section. (1)(i) Postmarketing 15-day "Alert reports." The applicant shall report each adverse drug experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the applicant. (ii) Postmarketing 15-day "Alert reports"—follow up. The applicant shall promptly investigate all adverse drug experiences that are the subject of these postmarketing 15-day Alert reports and shall submit follow up reports within 15 calendar days of receipt of new information or as requested by FDA. If additional information is not obtainable, records should be maintained of the unsuccessful steps taken to seek additional information. Postmarketing 15-day Alert reports and follow ups to them shall be submitted under separate cover. (iii) Submission of reports. The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section, concerning the submission of postmarketing 15-day Alert reports, shall also apply to any person other than the applicant (nonapplicant) whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor. To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of this section, obligations of a nonapplicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a nonapplicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the nonapplicant shall submit each report to the applicant within 5 calendar days of receipt of the report by the nonapplicant, and the applicant shall then comply with the requirements of this section.

Company Z selected a proprietary name for its new molecular entity, currently in development. The NDA will be submitted in six months. All of the following are relevant to the proprietary name EXCEPT: A. The request for proprietary name approval may be submitted with the NDA. B. The proprietary name submission package may be submitted up to one month after NDA submission. C. The request for proprietary name approval may be submitted prior to the NDA. D. FDA will inform the applicant prior to the action date whether the proprietary name is acceptable.

B. The proprietary name submission package may be submitted up to one month after NDA submission. The request for proprietary name approval must be submitted no later than in the NDA. Companies have the option of submitting a proprietary name request prior to NDA submission under the Investigational New Drug application (IND). FDA review of proprietary names evaluates both the proposed names' safety and promotional aspects. FDA will inform the applicant prior to the action date whether the proprietary name is acceptable and will offer suggestions if the proposed name is deemed unacceptable. Sec. 314.50 Content and format of an application. (a)Application form. The applicant shall submit a completed and signed application form that contains the following: (1) The name and address of the applicant; the date of the application; the application number if previously issued (for example, if the application is a resubmission, an amendment, or a supplement); the name of the drug product, including its established, proprietary, code, and chemical names;

The two mechanisms to amend an OTC Monograph are: A. Time & Extent Application (TEA) or Annual Report B. Time & Extent Application (TEA) or Citizen Petition C. Annual Report or Preapproval Supplement D. Citizen Petition or Preapproval Supplement

B. Time & Extent Application (TEA) or Citizen Petition

Who is ultimately accountable for ensuring that subject's rights, safety and welfare are protected in clinical trial research? A. Primary investigator B. Trial sponsor C. Institutional Review Board D. Clinical trial site/institution

B. Trial sponsor While all of the aforementioned parties have responsibilities for clinical trial subject protection, the sponsor is ultimately accountable.

The drug substance manufacturer submitted a DMF to FDA for one of their drug substances. What type of DMF was submitted to FDA? Who does FDA notify when deficiencies are found in the DMF? A. Type I DMF and both sponsor and holder are notified. B. Type II DMF and both sponsor and holder are notified. C. Type I DMF and only DMF holder is notified. D. Type II DMF and only DMF holder is notified.

B. Type II DMF and both sponsor and holder are notified. B. See CDER Guideline for Drug Master Files (September 1989).

Under whose authority can an imported drug, device or biologic be detained or refused entry into the US? A. US Department of Agriculture B. US Customs C. FDA D. FBI

B. US Customs B. US Customs is the only US agency that has been granted authority to detain or refuse entry of imported products.

Under whose authority can an imported drug, device or biologic be detained or refused entry into the US? A. US Department of Agriculture. B. US Customs. C. FDA. D. FBI.

B. US Customs.

Under whose authority can an imported drug, device or biologic be detained or refused entry into the US? A. US Department of Agriculture. B. US Customs. C. FDA. D. FBI.

B. US Customs. US Customs is the only US agency that has been granted authority to detain or refuse entry of imported products.

While seeking a new Class III indication for a medical device that is currently on the market as Class II, a company received a vote of "non-approvable" from an FDA Advisory Panel. Possible course of action include all of the following EXCEPT: A. Continue marketing the device for its Class II indication B. Update the current labeling to include the new indication C. Proceed with a PMA submission to FDA D. Request a face-to-face meeting post-panel meeting with FDA

B. Update the current labeling to include the new indication Regulatory Reference: 21 CR 807.90-3; 21 CFR 801.4

While seeking a new Class III indication via a 510(k) for a medical device currently on the market as Class II, a company received a vote of "non-approvable" from an FDA Advisory Committee. Possible courses of action include all of the following EXCEPT: A. Continue marketing the device for its Class II indication B. Update the current labeling to include the new indication C. Proceed with a PMA submission to FDA D. Request a face-to-face post-panel meeting with FDA

B. Update the current labeling to include the new indication The medical device would be considered misbranded because the agency has not approved the indication and labeling.

All of the flowing are considered well-characterized biologics and have been moved from CBER to CDER except: A. Non-vaccine therapeutic immunotherapies B. Vaccines C. Cytokines D. Monoclonal antibodies for in vivo use

B. Vaccines

Removal of a distributed product for a reason NOT subject to legal action by FDA is known as: A. Product recall B. Stock recovery C. Market withdrawal D. Corrective action

C. Market withdrawal Market withdrawal applies when a firm removes or corrects a distributed product which involves a minor violation that would not be subject to legal action by FDA, e.g. normal stock rotation practices, routine equipment adjustments and repairs. See 21 CFR 7.3(j).

A company has a new blood pressure medication, NOSTRESS. The clinical trials are completed and demonstrate similar safety and efficacy to those drugs currently on the market. The clinical data are ready for submission to FDA. The Chemistry, Manufacturing and Controls data are not ready, but will be ready in two months. What is the fastest way to file this NDA? A. Submit NDA as a Rolling Review B. Wait until the CMC data are ready to submit C. File the NDA with the clinical data and update the CMC data in the four-month update D. Request Fast Track designation

B. Wait until the CMC data are ready to submit Rolling review and Fast Track are only for drugs that treat serious disease and meet an unmet medical need; the four-month safety report is for clinical safety only.

Removal of a distributed product for a reason NOT subject to legal action by FDA is known as: A. Product recall. B. Stock recovery. C. Market withdrawal. D. Corrective action.

C. Market withdrawal. Market withdrawal applies when a firm removes or corrects a distributed product which involves a minor violation that would not be subject to legal action by the FDA, e.g. normal stock rotation practices, routine equipment adjustments and repairs 21 CFR 7.3(j).

A company has a new blood pressure medication, NOSTRESS. The clinical trials are completed and demonstrate similar safety and efficacy to those drugs currently on the market. The clinical data are ready for submission to FDA. The Chemistry, Manufacturing and Controls data are not ready, but will be ready in two months. What is the fastest way to file this NDA? A. Submit NDA as a Rolling Review B. Wait until the CMC data are ready to submit C. File the NDA with the clinical data and update the CMC data in the four-month update D. Request Fast Track designation

B. Wait until the CMC data are ready to submit Rolling review and Fast Track are only for drugs that treat serious disease and meet an unmet medical need; the four-month safety report is for clinical safety only.

Laboratories do NOT need to obtain a certificate under CLIA to perform: A. Cleared tests B. Waived tests C. Exempt tests D. High complexity tests

B. Waived tests

To be legally effective, a witness must observe the informed consent process at which of the following times? A. When the study subject is a minor B. When the elements of informed consent are presented orally C. When the consent is obtained from the subject's legal representative D. When the elements of informed consent are written in a foreign language

B. When the elements of informed consent are presented orally FDA regulations require a witness to an oral presentation of elements of informed consent to the subject or the subject's legally authorized representation; see 21 CFR 50.27(b)(2).

Under the statutory violations, failure to meet 510(k) requirements for a device that is required to have a 510(k) and is in commercial distribution is considered to be: A. Adulteration. B. Improper use C. Misbranded D. Fraudulent

C. Misbranded A marketed device that needs a 510(k) for commercialization but failed to comply with the requirements is considered to be Misbranded. See the FD&C Act, 502(o).

Under the statutory violations, failure to meet 510(k) requirements for a device that is required to have a 510(k) and is in commercial distribution is considered to be: A. Adulteration. B. Improper use C. Misbranded D. Fraudulent

C. Misbranded A marketed device that needs a 510(k) for commercialization but failed to comply with the requirements is considered to be Misbranded. See the FD&C Act, 502(o).

Under the statutory violations, lack of an approved PMA for a PMA device that is not exempt and is in commercial distribution is considered to be: A. Adulteration. B. Improper use. C. Misbranded. D. Fraudulent.

C. Misbranded.

In the original application for drug "X," your company submitted a comparability protocol outlining a series of proposed, repetitive container closure system changes, the tests and studies that would be used to evaluate the changes, and the acceptance criteria that would be met. The application has since been approved. Subsequently, the comparability test results did not meet some of the predefined acceptance criteria. What regulatory option does your company have in this situation? A. Your company may implement the change(s), but an explanation as to why some of the acceptance criteria were not met must be included within the next Annual Report B. Your company may still pursue the change(s) and should submit a Prior Approval Supplement that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness C. Your company may still pursue the change(s) and should submit a CBE-30 that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness D. There is no further regulatory option; the proposed change(s) cannot be implemented since the predefined acceptance criteria were not met.

B. Your company may still pursue the change(s) and should submit a Prior Approval Supplement that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness If test results do not meet the acceptance criteria, the company may elect not to implement the change. However, it still has the option to pursue the change(s) by submitting a Prior Approval Supplement to provide supporting data to justify why the change won't adversely affect the drug product.

The following biological products are regulated by CBER EXCEPT: A. Immunizing toxoids B. Monoclonal antibodies for in vitro use C. Monoclonal antibodies for in vivo use D. Infusion of animal sourced cells into a human

C. Monoclonal antibodies for in vivo use Monoclonal antibodies for in vivo use were transferred to CDER's Office of New Drugs (OND) effective 30 June 2003.

A drug that has both a high potential for abuse and at least one accepted medical use in the United States is scheduled by which of the following? A. Substance Abuse, Mental Health Services Administration (SAMHSA) B. Drug Enforcement Administration C. National Center for Toxicological Research (NCTR) D. Food and Drug Administration

C. National Center for Toxicological Research (NCTR) A. SAMHSA is responsible for all concerns with substance abuse and mental illness. B. DEA enforces the controlled substance laws and regulations as they pertain to the manufacturing, distribution and dispensing of legally produced controlled substances. C. NCTR conducts peer reviewed scientific research that supports and anticipates FDA's current and future regulatory needs. D. FDA does not have the statutory authority and does not schedule drugs with abuse liability.

5 -year exclusivity is given to which of the following applications: A. Orphan drug B. Pediatric C. New Chemical Entity (NCE) D. Patent Challenge (PC)

C. New Chemical Entity (NCE)

What additional FDA clearances are required to export a drug approved by FDA? A. Certificate of Free Sale B. Customs Tax Stamps C. No clearance required D. FDA receipt for sample Form-484

C. No clearance required A. Certificate of Free Sale is not an FDA requirement. B. Customs tax stamps might be appropriate for the receiving country, but are not an FDA requirement. C. There are no FDA export requirements for approved products. D. An FDA Form 484 receipt for sample has no relevance to exporting an approved product.

What additional FDA clearances are required to export a drug approved by FDA when the drug will be used for its approved use? A. Certificate of Free Sale B. Customs Tax Stamps C. No clearance required D. FDA receipt for sample Form-484

C. No clearance required There are no FDA export requirements for approved products.

What additional FDA clearances are required to export a drug approved by FDA? A. Certificate of Free Sale. B. Customs Tax Stamps. C. No clearance required. D. FDA receipt for sample Form-484.

C. No clearance required. There are no FDA export requirements for approved products.

In the original application for drug "X," your company submitted a comparability protocol outlining a series of proposed, repetitive container closure system changes, the tests and studies that would be used to evaluate the changes, and the acceptance criteria that would be met. The application has since been approved. Subsequently, the comparability test results did not meet some of the predefined acceptance criteria. What regulatory option does your company have in this situation? A. Your company may implement the change(s), but an explanation as to why some of the acceptance criteria were not met must be included within the next Annual Report B. Your company may still pursue the change(s) and should submit a Prior Approval Supplement that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness C. Your company may still pursue the change(s) and should submit a CBE-30 that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness D. There is no further regulatory option; the proposed change(s) cannot be implemented since the predefined acceptance criteria were not met.

B. Your company may still pursue the change(s) and should submit a Prior Approval Supplement that provides the supporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug product as these factors relate to the product's safety and effectiveness If test results do not meet the acceptance criteria, the company may elect not to implement the change. However, it still has the option to pursue the change(s) by submitting a Prior Approval Supplement to provide supporting data to justify why the change won't adversely affect the drug product.

Advertising and promotional materials are required to be submitted to FDA at the time of initial dissemination or publication for all products EXCEPT: A. Prescription Drugs B. Biologics C. Non-restricted devices and OTC drugs D. None, all products require submission of advertising and promotional material.

C. Non-restricted devices and OTC drugs Non-restricted medical device and OTC drug advertising is regulated by the Federal Trade Commission (FTC) under the FTC Act.

In order to ensure that a facility complies with GMP requirements, all of the following features should be evaluated except: A. the air handling system B. animal supply facilities C. lighting D. potable water

B. animal supply facilities A. According to 21 CFR 211.46, air-handling system evaluation is required. Environmental control and monitoring is also mandated by 21 CFR 820.70 (c) QSR, (see also Medical Device Quality Systems Manual: A Small Entity Compliance Guide), and 21 CFR 1271.195 (a) GTPs. B. Evaluation of animal supply facilities does not fall under GMP, but rather falls under GLP, 21 CFR 58.45. C. According to 21 CFR 211.44, lighting system evaluation is required. See also Medical Device Quality Systems Manual: A Small Entity Compliance Guide. 21 CFR 1271.190 (a) (GTPs) states that lighting must be adequate. D. According to 21 CFR 211.48, potable water system evaluation is required. 21 CFR 1271.190 (a) states that plumbing and drainage must be adequate.

The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the following EXCEPT: A. conduct quality audits by individuals who do not have direct responsibility for the operation being audited B. audit operations annually C. document the dates and results of quality audits and re-audits D. have the findings reviewed by management responsible for the matters audited

B. audit operations annually A. True. This is required under 21 CFR 820.22. B. False. Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency to determine that quality system activities comply with quality system procedures. C. True. See explanation A. D. True. See explanation A.

Inspections of device components received from a supplier may frequently reveal product quality deficiencies. To avoid these instances, the supplier should first have: A. expert GMP knowledge B. clear and precise specifications from the manufacturer C. detailed knowledge of the manufacturer's operations D. an internal audit program

B. clear and precise specifications from the manufacturer A. It is the implementation and monitoring of GMP that helps avoid quality deficiencies. B. An agreement outlining the manufacturer's specifications would minimize quality deficiencies. 21 CFR 820.81(b). C. The supplier need not be familiar with the manufacturer's operations. D. This does not address the issues of definitions of specifications and acceptable quality levels.

The purpose of a Phase I clinical study is to: A. establish the tolerability of a new drug in patient subjects B. establish the safety of a new drug in healthy subjects C. establish the efficacy of a new drug in healthy subjects D. establish the dosage of a new drug in patient subjects

B. establish the safety of a new drug in healthy subjects

Which of the following is a key provision of the Medical Device User Fee and Modernization Act? A. establishes user fees for HDEs, IDEs, and pediatric uses B. establishment inspections by FDA-accredited third-party reviewers C. establishes mandatory listing of Class I and Class II medical devices D. complete review of manufacturing supplements in six months

B. establishment inspections by FDA-accredited third-party reviewers A. MDUFMA established exemptions from user fees for HDEs, IDEs, and medical devices for pediatric uses. B. This is one of the key provisions MDUFMA established. C. MDUFMA was not responsible for this requirement. D. 180-day review is standard review time for manufacturing supplements to PMA approved products.

Consent from subjects for clinical study enrollment is a: A. proposed rule. B. final rule. C. recommendation. D. guideline.

B. final rule. The FDA regulation on informed consent became a final rule on 27 January 1981. 21 CFR 50

The Quality System Regulation for medical devices published in the Federal Register in October 1996 pertains to manufacturing of which of the following? A. finished devices and components of finished devices B. finished devices and accessories to finished devices C. finished devices, but not accessories D. finished devices, components, and accessories to finished devices

B. finished devices and accessories to finished devices A. Components are specifically excluded from this regulation. B. This regulation applies to finished devices and the definition of "finished devices" includes accessories. C. This regulation applies to finished devices, which includes accessories. 21 CFR 820.3(l). D. Components are excluded from this regulation.

Subacute toxicity testing should be performed: A. in two rodent species B. in one rodent and one non-rodent species C. for a minimum of two weeks D. for a minimum of six months

B. in one rodent and one non-rodent species A. See explanation B. B. See ICH guideline M3 Maintenance of The ICH Guideline on Non-Clinical Safety Studies for The Conduct of Human Clinical Trials for Pharmaceuticals. C. See explanation B. D. See explanation B.

Which of the following is NOT true regarding ANDAs filed under paragraph IV certification? A. They allow companies to seek approval of an ANDA before the expiration date of the patent for the reference drug. B. The first company to receive approval of the ANDA has exclusive marketing rights for 180 days. C. Notification of the ANDA submission to the original patent holder is not required at the time of submission D. Patent holders have 45 days to file an infringement suit against the filer.

C. Notification of the ANDA submission to the original patent holder is not required at the time of submission Notification to the original patent holder is required per 21 CFR 314.95(a).

An Investigational New Drug Application (IND) was submitted to FDA. New animal toxicology data is obtained and will be submitted to FDA as an: A. information amendment submitted no more than every 60 days. B. information amendment submitted no more than every 30 days. C. information amendment submitted no more than every 45 days. D. information supplement submitted with the Annual Report.

B. information amendment submitted no more than every 30 days. Per 21 CFR 312.31, "a sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include: (1) New toxicology, chemistry, or other technical information; or (2) A report regarding the discontinuance of a clinical investigation." Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.

A company is using a clinical research organization (CRO) to develop the protocol and monitor the clinical investigators for the company's clinical trial. The regulatory affairs professional may interact with the CRO in which of the following situations? A. making presentations to the reviewing IRBs B. making presentations to the reviewing division at FDA C. witnessing the signing of patient consent forms D. arranging for FDA investigators to observe treatment of subjects at clinical sites

B. making presentations to the reviewing division at FDA A. Monitors and sponsors do not interact with IRBs. It is the clinical investigator's responsibility to obtain IRB approval. B. The CRO may assist in explaining the clinical protocol or data to FDA. C. Monitors and sponsors cannot witness signing of patient consent forms. This is the clinical investigator's responsibility. D. FDA does not observe patient treatments, but may inspect clinical study records.

All of the following are considered General Controls under the Food, Drug & Cosmetic Act EXCEPT: A. establishment registration B. premarket approval application C. medical device reporting D. listing of the device

B. premarket approval application A. This is an example of General Controls mentioned in the FD&C Act. See www.fda.gov/cdrh/devadvice/363.html. (c) B. PMA is not a general control. C. See explanation A. D. See explanation A.

When assembling an NDA, all of the following FDA guidelines are used EXCEPT: A. environmental assessment of human drugs and biologics application. B. preparation of an IND product. C. format and content of an application summary. D. format and content of clinical and statistical sections.

B. preparation of an IND product. A. This is a guidance document that will help the regulatory professional assemble an NDA B. This guidance is useful in describing how to assemble an IND, the phase of drug development that precedes an NDA C.This is a guidance document that will help the regulatory professional assemble an NDA D.This is a guidance document that will help the regulatory professional assemble an NDA

An IRB will review the following EXCEPT: A. risks and benefits of the proposed research B. risks and benefits of alternative therapies C. prospective informed consent document D. provisions to protect the privacy of subjects

B. risks and benefits of alternative therapies A. FDA regulations (21CFR 56.111) require an IRB to review risks to determine that they are minimal in relation to anticipated benefits. B. FDA regulations do not require an IRB to assess the risks or benefits of alternatives. C. FDA regulations (21CFR 56.111) require an IRB to determine that informed consent will be documented in accordance with the regulations. D. FDA regulations (21CFR 56.111) require an IRB to determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.

In order to implement and maintain a Quality System, which of the following subsystems is NOT required by FDA? A. production and process controls B. test and control article characterization C. packaging and labeling controls D. buildings and facilities

B. test and control article characterization A. This is required by 21 CFR 211.100 (drugs), and by 21 CFR 820.70 (devices). B. This is required by 21 CFR 58.105, Good Laboratory Practice for Nonclinical Laboratory Studies, not by quality system or GMP requirements. Note that Laboratory controls for finished pharmaceuticals are required by 21CFR 211, Subpart I. C. This is required by 21 CFR 211.122 (drugs) and by 21 CFR 820.120, 20.130 (devices). D. This is required by 21 CFR 211.42 (drugs) and by 21 CFR 820.70 (devices).

The protocol for a nonclinical laboratory study must contain all of the following EXCEPT: A. the species, strain and age of the test system B. the dated signature of the sponsor representative C. a description of the methods for the control of bias D. the type and frequency of tests and measurements

B. the dated signature of the sponsor representative A. This is required. 21 CFR 58.120(a)(4). B. The only person required to sign and date a nonclinical study protocol is the study director. Only the date approval of a sponsor representative must be included. 21 CFR 58.120(a)(11). C. This is required. 21 CFR 58.120(a)(6). D. This is required. 21 CFR 58.120(a)(9).

A pharmaceutical firm wishes to develop a generic version of an approved antibiotic. The Orange Book has no patent information listed The regulatory affairs practitioner should file an ANDA: A. without patent certification since none is required. B. with Paragraph 1 certification stating that "patent information has not been submitted to FDA." C. suitability petition to determine whether the new drug application can be submitted in an abbreviated format. D. supported by Safety and Efficacy studies.

B. with Paragraph 1 certification stating that "patent information has not been submitted to FDA." A. A patent certification is not necessary for antibiotics since Title I does not apply. See the Preamble to Title I Regulations. B. Title I does not apply to antibiotics. C.Generics are allowed for any antibiotics which are the subject of an approved NDA D. This is not necessary for AND As and is covered in the approved original NDA

Your company is developing a new drug to be developed and used in combination with a cystoscopic light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is: A. Submit a Request for Designation to FDA Office of Combination Products for determination of the lead center for primary jurisdiction for the combination product B.Make a preliminary internal company determination of the combination product's primary mode of action C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug Products (OODP) D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products

B.Make a preliminary internal company determination of the combination product's primary mode of action

A new Class II device with electrical components was subjected to extensive standard testing such as the International Electrotechnical Commission (IEC) series (recognized conformance standard). The tests were conducted by a third party. Which route of submission is the most suitable for this device? A Traditional 510k B Special 510k C Abbreviated 510k D PMA

C Abbreviated 510k A manufacturer has the option to submit an Abbreviated 510(k) when FDA has recognized relevant consensus standards that are applicable to the device. This Abbreviated 510(k) will include a declaration of conformity to the recognized consensus standards, and this declaration, in many cases, should eliminate the need to review actual test data for those aspects of the device addressed by the standards, thus the review will be more efficient. Regulatory Reference: FD&C Act Section 514 ; The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications—Final Guidance ; Guidance for Industry and FDA Staff: Recognition and Use of Consensus Standards ; FDA Standards Database Search (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm) ; 21 CFR Part 814.

In a medical device company, which of the following units has ultimate responsibility for the integrity of the data and the quality of the product: A Quality Assurance B Quality Control C Management D Regulatory Compliance

C Management Management has the ultimate responsibility to ensure that the quality systems are effective and a quality policy is implemented and followed as intended, which assures the integrity of the data and quality of the product. Regulatory Reference: 21 CFR 820.20(a).

The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the following EXCEPT: A) 21 CFR 50 Protection of Human Subjects B) 21 CFR 56 IRB C) 21 CFR 807 Establishment Registration D) 21 CFR 812 IDE Exemptions

C) 21 CFR 807 Establishment Registration Part 812 - Only covering setting up Clinical Trial - Requirements for what happens during a trial will be covered later. Part 50 - Mention Foreign Studies here. These regulations apply only to studies conducted in the USA. FDA will accept foreign data for marketing submissions. March 2001 guidance reaffirmed for devices FDA will accept data provided 1983 version of Declaration of Helsinki or the laws/regulations of the country the study is being conducted in are followed (whichever is stricter). Foreign data - similar protocol, applicable populations, etc. Part 54 - published Feb. 2, 1998. Submit information in marketing application Purpose to identify and disclose financial interests/agreements of clinical investigators that may affect the integrity of the data Part 56 - Purpose of IRB is to protect the rights and welfare of human subjects

The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the following except: A) 21 CFR 50 Protection of Human Subjects B) 21 CFR 56 IRB C) 21 CFR 807 Establishment Registration D) 21 CFR 812 IDE Exemptions

C) 21 CFR 807 Establishment Registration Part 812 - Only covering setting up Clinical Trial - Requirements for what happens during a trial will be covered later. Part 50 - Mention Foreign Studies here. These regulations apply only to studies conducted in the USA. FDA will accept foreign data for marketing submissions. March 2001 guidance reaffirmed for devices FDA will accept data provided 1983 version of Declaration of Helsinki or the laws/regulations of the country the study is being conducted in are followed (whichever is stricter). Foreign data - similar protocol, applicable populations, etc. Part 54 - published Feb. 2, 1998. Submit information in marketing application Purpose to identify and disclose financial interests/agreements of clinical investigators that may affect the integrity of the data Part 56 - Purpose of IRB is to protect the rights and welfare of human subjects

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? A) A PMA B) A Special 510k C) An Abbreviated 510k D) An Annual Report for a PMA

C) An Abbreviated 510k Regulatory Reference: The New 510(k) Paradigm — Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, Final Guidance, 20 March 1998 and 21 CFR 807.81 (a)(3).

An important distinction of a Humanitarian Use Device (HUD) according to the Humanitarian Device Exemption (HDE) is that: A) The HDE application must contain the same i, B) An HDE application is not required to conta C) An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose. D) An HDE application must be within 30 days a

C) An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose. Regulatory Reference: 21 CFR Part 814 (Subpart H)

Which of the following is a true statement regarding advertising/promotion of prescription drug products? A) All promotional materials must be approved by FDA prior to use B) All promotional materials must be approved by the Federal Trade Commission C) Broadcast communication directing the audience to "see your doctor" for certain medical conditions or diseases" is not regulated by FDA D) Advertising is not allowed for drugs approved under accelerated approval/Subpart H

C) Broadcast communication directing the audience to "see your doctor" for certain medical conditions or diseases" is not regulated by FDA A: With limited exception, FDA does not "approve" advertisements and promotional labeling There can be situations where the promotional piece must be submitted to FDA for pre-approval; for example: accelerated approval drugs, part of an enforcement action, "extraordinary circumstances" B: not true. D: Promotion is allowed but must be submitted either within 120 days of marketing approval or 30 days prior to dissemination 21 CFR 314.550

You, a regulatory affairs professional, receive a warning letter from DDMAC pertaining to DTC advertising. The first thing you do is: A) Develop a corrective advertisement B) Write a response letter to DDMAC C) Cease dissemination of violative materials D) Review the marketing application

C) Cease dissemination of violative materials This is a good example where all responses are things you could do in this situation. However, the key word is first so this guides you towards the best answer.

For a marketed product, which of the following is not an example of a "prior approval" supplement? A) Manufacturing process change B) Change impacting product sterility C) Deletion or reduction of substance intended only to affect color of the drug product D) Delete specification for drug substance

C) Deletion or reduction of substance intended only to affect color of the drug product Annual reportable Annual Report -Delete/reduce ingredient to affect color -Changes to comply with official compendium -Editorial change to label Prior approval -New analytical procedure -Formulation changes -New manufacturing site with no or unsatisfactory GMP inspection -Change in manufacturing process

Which of the following is NOT true regarding ANDAs filed under paragraph IV certification? A. They allow companies to seek approval of an ANDA before the expiration date of the patent for the reference drug. B. If more than one company files paragraph IV certification on the first day, all share exclusive marketing rights for 180 days. C. Notification of the ANDA submission to the original patent holder is not required at the time of submission. D. Patent holders have 45 days to file an infringement suit against the filer.

C. Notification of the ANDA submission to the original patent holder is not required at the time of submission. Notification to the original patent holder is required per 21 CFR 314.95(a).

You have just been hired as Director of Regulatory Affairs at a contract sterilizer from a similar position at a surgical instrument manufacturer and are reviewing your firms' records. You haven't come across any device listing forms for the devices your firm sterilizes that are commercially available in the U.S. Which of the following responses is correct? A) Contact FDA to request a large number of Device Listing forms and assign a member of your staff to begin completing a form for each device your firm sterilizes. B) Exclude devices from foreign manufacturers from the list being prepared above. C) Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.

C) Find something else to worry about, contract sterilizers are not required to submit Device Listing forms for the devices they manufacture.

The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following: A) Finished devices, but not accessories B) Finished devices and components of finished devices C) Finished devices and accessories to finished devices D) Finished devices, components, and accessories to finished devices

C) Finished devices and accessories to finished devices

Which of the following is NOT true regarding ANDAs filed under paragraph IV certification? A. They allow companies to seek approval of an ANDA before the expiration date of the patent for the reference drug. B. If more than one company files paragraph IV certification on the first day, all share exclusive marketing rights for 180 days. C. Notification of the ANDA submission to the original patent holder is not required at the time of submission. D. Patent holders have 45 days to file an infringement suit against the filer.

C. Notification of the ANDA submission to the original patent holder is not required at the time of submission. Notification to the original patent holder is required per 21 CFR 314.95(a).

Because of reported dispensing errors due to the similarity of proprietary drug names, one of the companies involved has decided to quickly and voluntarily notify physicians and others responsible for providing patient care about the issue via a "Dispensing Error Alert". In this approach, the company is NOT required to: A. Use first class mail and number 10 white envelopes B. Use appropriate language on the outside of the mailing envelope which indicates the nature of the alert C. Notify FDA of it's action prior to disseminating the dispensing alert notification D. Include it's name and address in the upper left hand corner of the envelope

C. Notify FDA of it's action prior to disseminating the dispensing alert notification

Which of the following examples do not meet the definition of adulteration? A) A bottle of aspirin (for public retail sale) that is not packaged in tamper-resistant packaging B) Batch record was accidentally destroyed C) Incorrect lot number on the label D) A drug recognized in the USP/NF that does not meet all compendium standards

C) Incorrect lot number on the label This is a misbranded NOT adulterated In general - adulterated means safety and/or efficacy of product in question. Misbranded means incorrectly labeled. United States Pharmacopeia/National Formulary (USP/NF): privately published, official compendium containing standards, specifications and other requirements related to drugs and other articles used in medical and pharmacy practice. A drug recognized in USP/NF must meet all compendium standards or is considered adulterated and/or misbranded Misbranding is generally label oriented Adulteration is the actual or potential contamination of drug product

The Quality System Regulation (QSR) for medical devices (21CFR 820) requires all of the following except: A) Management to make a commitment to quality B) A Quality Plan that defines how quality will be met C) Management must review the Quality System at least quarterly D) A Quality representative must be identified and documented

C) Management must review the Quality System at least quarterly Remember, I said that the QSR is written in a "generic" voice where what you are expected to do is stated but HOW you accomplish the requirement is not detailed.

When should the manufacturer of a Class III medical device expect to have an FDA establishment registration inspection? A) Following submission of an IDE application B) After Phase II of the IDE study C) Prior to approval of the PMA D) Within 2 years following the PMA approval

C) Prior to approval of the PMA Regulatory Reference: 21 CFR 807

Because of reported dispensing errors due to the similarity of proprietary drug names, one of the companies involved has decided to quickly and voluntarily notify physicians and others responsible for providing patient care about the issue via a "Dispensing Error Alert". In this approach, the company is NOT required to: A. Use first class mail and number 10 white envelopes. B. Use appropriate language on the outside of the mailing envelope which indicates the nature of the alert. C. Notify FDA of it's action prior to disseminating the dispensing alert notification. D. Include it's name and address in the upper left hand corner of the envelope.

C. Notify FDA of it's action prior to disseminating the dispensing alert notification.

ADEs that do not meet 15-day reporting requirements should be reported by the applicant: A) Annually, unless alternate reporting arrangement is required by FDA B) Semi-annually, unless alternate reporting arrangement is required by FDA C) Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA D) Quarterly for 1st year after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA

C) Quarterly for 3 years after application is approved, annually thereafter, unless alternate reporting arrangement is required by FDA Report serious and unexpected ADEs as 15-day alert reports (initial and follow-up) Report all other ADEs quarterly for 3 years from date of approval of the application then annually thereafter. FDA may reestablish quarterly reporting, eg, after approval of a supplement, or alternate reporting requirement Adverse Drug Experience (ADE): Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including event related to accidental or intentional overdose, drug abuse, drug withdrawal, failure of expected pharmacological action Serious ADE: any ADE at any dose that results in death, life-threatening experience, inpatient hospitalization, prolongation of hospitalization, significant disability/incapacity, OR congenital anomaly/birth defect Unexpected ADE: any ADE that is not listed in current labeling for the drug product. Includes events that may be symptomatically or pathophysiologically related to a labeled event but differ because of greater severity or specificity

Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? A) Special PMA Supplements/CBE B) PMA Manufacturing Site Change Supplements C) Real Time Supplement D) 30 Day Notices 135 Day Supplements

C) Real Time Supplement

Design Control "verification" requires which of the following: A) The product design meets the users needs B) The process produces a product that meets predetermined specifications C) The product design meets specified requirements D) The product design meets the intended use requirements

C) The product design meets specified requirements

Design Control "verification" requires which of the following: A) The product design meets the users needs B) The process produces a product that meets predetermined specifications C) The product design meets specified requirements D) The product design meets the intended use requirements

C) The product design meets specified requirements Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Design validation means establishing by objective evidence that the device specifications conform with user needs and intended uses(s).

In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using two of your approved drugs in a new combination

C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information Choices A, B and D fall squarely within the scope of an IND. (key words - new indication, ie off label use) In response C, there is no mention of drug being given; simply collection of blood samples which would require informed consent and IRB approval but not an IND. Remember that an IND application provides an exemption from premarketing approval requirements and allows you to legally ship drug to conduct the proposed clinical study. You may not initiate a clinical study without an active IND and approval from the IRB(s)

You have been asked to review the draft label that will be used in the first clinical study for an investigational IVD which is not subject to IDE requirements. What statement must be included? A. "For in vitro diagnostic use" B. "For Research Use Only. Not for use in diagnostic procedures." C. "For Investigational Use Only. The performance characteristics of this product have not been established." D. "Made in USA"

C. "For Investigational Use Only. The performance characteristics of this product have not been established."

A physician reports to a manufacturer that a patient was hopitalized with acute sepsi after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days B. 15 calendar days C. 30 calendar days D. the next quarterly or annual report

C. 30 calendar days

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days B. 15 calendar days C. 30 calendar days D. The next quarterly or annual report

C. 30 calendar days Serious injury must be reported within 30 days; see 21 CFR 803.50(a).

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days C. 30 calendar days. D. The next quarterly or annual report.

C. 30 calendar days. C. Serious injury must be reported within 30 days. 21 CFR 803.50(a).

A sponsor submitted an original IDE/IND application. If the sponsor has not received any response form FDA, what is the earliest that clinical studies can be initiated? A. The sponsor must wait for FDA approval B. Upon IRB approval from any study center C. 30 days from receipt by FDA D. 90 days from receipt by FDA

C. 30 days from receipt by FDA A. FDA must eventually clear an IDE/IND. The regulations do allow for a study to begin 30 days after FDA receives the original application unless FDA has notified the sponsor differently. See explanation C. B. IRB approval is site-specific and still requires FDA approval prior to initiating studies. C. The IDE/IND goes into effect in 30 days unless FDA notifies the sponsor that the IDE/IND is on clinical hold. 21 CFR 812.30 (a)(1), 312.40(b)(1). D. See explanation C.

A sponsor submitted an original IDE/IND application. If the sponsor has not received any response from the FDA, what is the earliest that clinical studies can be initiated? A. The sponsor must wait for FDA approval. B. Upon IRB approval from any study center. C. 30 days from receipt by FDA. D. 90 days from receipt by FDA.

C. 30 days from receipt by FDA.

A sponsor submitted an original IDE/IND application. If the sponsor has not received any response from the FDA, what is the earliest that clinical studies can be initiated? A. The sponsor must wait for FDA approval. B. Upon IRB approval from any study center. C. 30 days from receipt by FDA. D. 90 days from receipt by FDA.

C. 30 days from receipt by FDA. The IDE/IND goes into effect 30 days after receipt by FDA, unless FDA notifies the sponsor that the IDE/IND is on clinical hold. 21 CFR 812.30 (a)(1), 312.40(b)(1).

A sponsor submitted an original IDE/IND application. If the sponsor has not received any response from FDA, what is the earliest that clinical studies can be initiated? A. The sponsor must wait for FDA approval. B. Upon IRB approval from any study center C. 30 days from receipt of IND by FDA D. 90 days from receipt of IND by FDA

C. 30 days from receipt of IND by FDA The IDE/IND goes into effect 30 days after receipt by FDA, unless FDA notifies the sponsor that the IDE/IND is on clinical hold. See 21 CFR 812.30 (a)(1), 312.40(b)(1).

Which of the following is the best regulatory pathway for drugs containing similar active ingredients as a previously approved drug for a new indication? A. 505(j) ANDA B. 505(b)(1) NDA C. 505(b)(2) NDA D. 505(d) Substantial Evidence of Effectiveness

C. 505(b)(2) NDA An application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference (section 505(b)(2)); Following are examples of changes to approved drugs for which 505(b)(2) applications should be submitted. - Active ingredient. An application for a change in an active ingredient such as a different salt, ester, complex, chelate, clathrate, racemate or enantiomer of an active ingredient in a listed drug containing the same active moiety. - Dosage form. An application for a change of dosage form, such as a change from a solid oral dosage form to a transdermal patch that relies to some extent upon the Agency's finding of safety and/or effectiveness for an approved drug. Strength. An application for a change to a lower or higher strength. - Route of administration. An application for a change in the route of administration, such as a change from an intravenous to intrathecal route. Substitution of an active ingredient in a combination product. An application for a change in one of the active ingredients of an approved combination product for another active ingredient that has or has not been previously approved.

A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy, and these studies are all published in peer-reviewed journals. The most-appropriate method to gain approval would be by filing a: A. ANDA B. SNDA C. 505(b)2 D. 505(b)1

C. 505(b)2 As the drug has been studied and results are published, a comparability study between IV and oral is acceptable under a 505(b)2.

A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy, and these studies are all published in peer-reviewed journals. The most-appropriate method to gain approval would be by filing a: A. ANDA B. SNDA C. 505(b)2 D. 505(b)1

C. 505(b)2 As the drug has been studied and results are published, a comparability study between IV and oral is acceptable under a 505(b)2.

If a company is planning to market a medical device that is substantially equivalent to a device marketed before 1976. t can use one of the following regulatory paths: A. IDE B. PMA C. 510(k) D. Special Assessment Protocol

C. 510(k) 510(k). Regulatory Reference: 21 CFR 807, Subpart E

If a company is planning to market a medical device that is substantially equivalent to a device marketed before 1976, which regulatory path would be most appropriate: A. IDE B. PMA C. 510(k) D. Special Assessment Protocol

C. 510(k) A device legally marketed prior to 28 May 1976 (pre-amendment device) can be used as a predicate device to demonstrate substantial equivalence as part of the Premarket Notification (510(k)).

If a company is planning to market a medical device that is substantially equivalent to a device marketed before 1976, which regulatory path would be most appropriate: A. IDE B. PMA C. 510(k) D. Special Assessment Protocol

C. 510(k) A device legally marketed prior to 28 May 1976 (pre-amendment device) can be used as a predicate device to demonstrate substantial equivalence as part of the Premarket Notification (510(k)).

A company is developing a new device, and the device classification under which it would fall is not clear. As the regulatory professional, you would make the following submission: A. 510(k) Premarket Notification B. Request for Designation C. 513(g) Request for Information D. Type A Meeting Request

C. 513(g) Request for Information A 510(k) submission is filed when you know the classification of the device and are comparing it to a predicate device in order to obtain FDA clearance. A Request for Designation is when you need FDA to determine whether your product is a drug, device, biological product or combination product. A Type A Meeting is needed to help an otherwise stalled product development program proceed. A 513(g) Request for Information is submitted to FDA as a request to determine the device classification and applicable requirements under the FD&C Act.

A company is developing a new device, and the device classification under which it would fall is not clear. As the regulatory professional, you would make the following submission: A. 510(k) Premarket Notification B. Request for Designation C. 513(g) Request for Information D. Type A Meeting Request

C. 513(g) Request for Information —A 510(k) submission is filed when you know the classification of the device and are comparing it to a predicate device in order to obtain FDA clearance. —A Request for Designation is when you need FDA to determine whether your product is a drug, device, biological product or combination product. —A Type A Meeting is needed to help an otherwise stalled product development program proceed. —A 513(g) Request for Information is submitted to FDA as a request to determine the device classification and applicable requirements under the FD&C Act.

In most cases, the manufacturer of biological products should retain samples for a minimum of what amount of time beyond the expiration date? A. 10 Days B. 30 Days C. 6 Months D. 12 Months

C. 6 Months Manufacturers shall retain for a period of at least six months after the expiration date, unless a different time period is specified in additional standards, a quantity of representative material of each lot of each product, sufficient for examination and testing for safety and potency, except Whole Blood, Cryoprecipitated AHF, Platelets, Red Blood Cells, Plasma, and Source Plasma and Allergenic Products prepared to a physician's prescription.

How mand days does FDA have to review an Abbreviated 510(k) A. 30 dayr B. 60 days C. 90 day D. 180 days

C. 90 day This question tests the examinee's familiarity with the Abbreviated 510(k). Because both Special 510(k)s and Abbreviated 510(k)s are alternate approaches to the Traditional 510(k) with the goal to streamline the evaluation of the application, while Special 510(k) review clock is 30 days, many people make the mistake of thinking that the review clock for an Abbreviated 510(k) is also 30 days. Regulatory Reference: Frequently Asked Questions on The New 510(k) Paradigm.

How many days does FDA have to review an Abbreviated 510(k)? A. 30 days B. 60 days C. 90 days D. 180 days

C. 90 days Because both Special 510(k) and Abbreviated 510(k) are alternate approaches to the Traditional 510(k), with the goal of streamlining evaluation of the application, the Special 510(k) review clock is 30 days. Many people often think the review clock for an Abbreviated 510(k) is also 30 days, but it is actually 90.

A manufacturer which of the following must file an IDE before conducting a human clinical study? A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time B. A device intended solely for veterinary use C. A custom device being studied for safety and effectiveness in support of commercial marketing D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time and intended solely for veterinary use

C. A custom device being studied for safety and effectiveness in support of commercial marketing While a custom device may be studied in humans without an IDE, if its safety and efficacy are being studied in support of commercial marketing, an IDE must be filed; see 21 CFR 812.2(c)(7).

Which of the following types of drug applications are NOT subject to a one-time FDA user fee upon submission of the application? A. An original NDA containing nonclinical and clinical data that have already been submitted to an IND B. A supplemental NDA containing previously unsubmitted nonclinical and clinical data C. A supplemental NDA requesting review of new and/or revised manufacturing processes D. An original NDA containing previously submitted nonclinical data and clinical data that has not been previously submitted to an IND

C. A supplemental NDA requesting review of new and/or revised manufacturing processes Any NDA or SNDA that contains new clinical data must pay a fee to FDA upon submission of the application.

A Class II device with electrical components was subjected to extensive standardized testing such as the International Electrotechnical Commission (IEC) series (recognized conformance standard). The tests were conducted by a third party. Which route of submission is the most suitable for this device? A. Traditional 510(k) B. Special 510(k) C. Abbreviated 510(k) D. PMA

C. Abbreviated 510(k) A manufacturer has the option to submit an Abbreviated 510(k) when FDA has recognized relevant consensus standards applicable to the device. This Abbreviated 510(k) will include a declaration of conformity to the recognized consensus standards, and this declaration, in many cases, should eliminate the need to review actual test data for those aspects of the device addressed by the standards, thus the review will be more efficient.

Because of reported dispensing errors due to the similarity of proprietary drug names, one of the companies involved has decided to quickly and voluntarily notify physicians and others responsible for providing patient care about the issue via a "Dispensing Error Alert". In this approach, the company is NOT required to: A. Use first class mail and number 10 white envelopes B. Use appropriate language on the outside of the mailing envelope that indicates the nature of the alert C. Notify FDA of its action prior to disseminating the dispensing alert notification D. Include its name and address in the upper left hand corner of the envelope)

C. Notify FDA of its action prior to disseminating the dispensing alert notification Because of the potential safety issue, the company may elect to act quickly and disseminate the "alert" without prior submission to FDA.

Because of reported dispensing errors due to the similarity of proprietary drug names, one of the companies involved has decided to quickly and voluntarily notify physicians and others responsible for providing patient care about the issue via a "Dispensing Error Alert". In this approach, the company is NOT required to: A. Use first class mail and number 10 white envelopes B. Use appropriate language on the outside of the mailing envelope that indicates the nature of the alert C. Notify FDA of its action prior to disseminating the dispensing alert notification D. Include its name and address in the upper left hand corner of the envelope

C. Notify FDA of its action prior to disseminating the dispensing alert notification Because of the potential safety issue, the company may elect to act quickly anddisseminate the "alert" without prior submission to FDA.

Because of reported dispensing errors due to the similarity of proprietary drug names, one of the companies involved has decided to quickly and voluntarily notify physicians and others responsible for providing patient care about the issue via a "Dispensing Error Alert". In this approach, the company is NOT required to: A. Use first class mail and number 10 white envelopes. B. Use appropriate language on the outside of the mailing envelope that indicates the nature of the alert. C. Notify FDA of its action prior to disseminating the dispensing alert notification. D. Include its name and address in the upper left hand corner of the envelope.

C. Notify FDA of its action prior to disseminating the dispensing alert notification. Because of the potential safety issue, the company may elect to act quickly and disseminate the "alert" without prior submission to FDA.

A pharmaceutical manufacturer has a high volume tablet product that requires the production of about 600 batches per year to meet demand. The batch records are generated from the same Master Production (Batch) Record. Each batch record calls for the calculation of the yield to be recorded three ways: theoretical yield; actual yield and percentage of theoretical yield. Which of these calculations would you expect to be most impacted by the amount of waste accumulated during the granulation process? A. All three yield calculations B. Theoretical yield C. Actual yield and percentage of theoretical yield D. None of the three yield calculations

C. Actual yield and percentage of theoretical yield To make the correct selection, one must understand anything that affects the actual yield, e.g., waste, samples pulled, etc., in any part of the process affects the percentage of theoretical yield calculation because the percentage of theoretical yield is defined as a ratio of the actual yield and then expressed as a percentage (see Part 210.3 (19)). Sec. 210.3 Definitions. (17) Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production. (18) Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product. (19) Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage. Sec. 211.103 Calculation of yield. Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product.

Which of the following is true of an Advisory Committee? A. Advisory Committee meetings do not include a closed portion B. Only FDA staff can make presentations at the Advisory Committee meeting C. Advisory Committees provide advice to FDA on safety and effectiveness of the drug product D. FDA must always follow the recommendations of the Advisory Committee

C. Advisory Committees provide advice to FDA on safety and effectiveness of the drug product A. Information prohibited from public disclosure under Part 20 and the regulations referenced therein are presented to the committee in a closed portion of its meeting. 21 CFR 14.25(c). B. Any interested person may make an oral presentation upon a request to the executive secretary before the meeting. 21 CFR 14.29(b). C. This is the purpose of the Advisory Committee. 21 CFR 14.160(a). D. The regulations do not require FDA to accept the recommendation of an Advisory Committee.

What products are exempt from the Prescription Drug User Fees Act (PDUFA)? A. Generic drugs only B. Orphan drugs and cosmetics only C. OTC drugs, cosmetics, generic drugs and medical devices D. Prescription drugs marketed before 1992

C. OTC drugs, cosmetics, generic drugs and medical devices

During a clinical study which is NOT the role of the sponsor? A. Control distribution of drugs B. Monitor studies C. Obtain informed consent D. Submit IND/Protocol to FDA if required

C. Obtain informed consent It is the investigator's responsibility to obtain the informed consent.

You work for a company that is developing an autologous cellular therapy product. FDA informed your company that its product will be regulated as an HCT/P (Human Cells, Tissues and Cellular and Tissue-Based Product). Based on this information, with which of the following regulatory requirements will your company need to be compliant when manufacturing the product? A. 21 CFR 210 / 211 (CGMP requirements for pharmaceuticals) B. 21 CFR 2171 and 21 CFR 820 C. All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility) D. All Subparts of 21 CFR 1271

C. All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility) As the product is regulated under section 361 of the PHS Act, it is only subject to the requirements in 21 CFR 1271, with the exception of Subpart C, as autologous products are not subject to donor eligibility requirements.

The marketing department has designed a journal advertisement that mentions leadership in a particular therapeutic area and includes only the name of the company's approved prescription drug products. Which of the following should be included in the advertisement to be in compliance with regulations? A. Full prescribing information. B. A brief summary of the prescribing information. C. All the available names of the drug product and the established name of each of the active ingredients in the drug product. D. A complete listing of adverse events.

C. All the available names of the drug product and the established name of each of the active ingredients in the drug product. Reminder advertisements are those advertisements which call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. 21 CFR 202.1(e)(2)(i).

An important distinction of a Humanitarian Use Device (HUD) according to the Humanitarian Device Exemption (HDE) is that: A. The HDE application must contain the same information as a PMA B. An HDE application is not required to contain the results of scientifically valid analytical safety studies C. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose D. An HDE application must be submitted within 30 days after marketing begins

C. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating effectiveness for its intended purpose

Your company is planning to submit a BLA to CBER. The BLA was pulled together quickly and you are concerned it may not be complete. FDA's initial filing decision could be a Refuse to File (RTF) for all of the reasons below EXCEPT: A. Data tabulations (line listings) or graphic displays cannot be interpreted B. Clear omission of required sections C. An analysis was conducted incorrectly D. Technically deficient electronic submission

C. An analysis was conducted incorrectly An RTF is issued when the necessary components of an application are missing or inadequate to be reviewed. A complete response letter (CR) is due to critical omissions of data or analysis as well as adverse judgment about the data, conclusions, rationale, etc., which would include an analysis being conducted incorrectly.

An IND application is: A. An application requesting an FDA meeting to discuss the sponsor's investigational plan for a compound B. An application requesting permission to start clinical trials in humans C. An application requesting federal exemption from interstate commerce law D. An application requesting permission to start nonclinical research trials in animals

C. An application requesting federal exemption from interstate commerce law The IND is not a request for approval; it is a request for exemption from federal law governing the movement of unapproved products across state lines.

A marketing department plans to launch a series of educational speaker's programs for one of the company's drug/biologic products. Which of the following statements does not apply? A. Substantial evidence or substantial clinical experience (where substantial evidence is defined as adequate and well-controlled studies) is required to substantiate all claims and conclusions presented. B. The company may suggest speakers or content for the presentations. C. An independent third-party organization must manage the seminar series. D. All speakers must disclose any financial relationships with the sponsoring company.

C. An independent third-party organization must manage the seminar series. Answer C is not applicable and this statement cannot be found in the FDA Guidance Industry-Supported Scientific and Educational Activities.

All of the following are requirements of an IRB, EXCEPT A. Has at least 5 members B. Includes at least 1 nonscientific member C. Obtains informed consent from all subjects D. Represents the cultural mix of the community

C. Obtains informed consent from all subjects A. It is a requirement that each IRB have at least 5 members (21 CFR56.107(a) B. The regulations require each IRB to have at least 1 member whose primary concerns are in the scientific area and at least 1 whose primary concerns are in nonscientific areas ((21 CFR56.107(c) C. It is the responsibility of the clinical investigator to obtain consent from all subjects, not the IRB (21 CFR 312.60) D. The regulations require each IRB to have a diversity of members (race, gender, cultural backgrounds ) (21 CFR56.107(a)

Under the IDE regulation, all of the following must be reported to the sponsor within five working days EXCEPT: A. A deviation from the investigational plan B. Withdrawal of IRB approval C. An unanticipated adverse device effect D. Use of a device without informed consent

C. An unanticipated adverse device effect Regulations An investigator shall notify the sponsor and IRB of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred. If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within 5 working days after the use occurs. Withdrawal of IRB Approval A sponsor shall notify FDA and all reviewing IRB's /investigators of any withdrawal of IRB approval within 5 working days after receipt of the withdrawal of approval. An investigator shall report to the sponsor, within 5 working days, a withdrawal of IRB approval An investigator shall submit to the sponsor and IRB a report of any unanticipated adverse device effect occurring as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.

Under the IDE regulation, all of the following must be reported to the sponsor within five working days EXCEPT: A. A deviation from the investigational plan. B. Withdrawal of IRB approval. C. An unanticipated adverse device effect. D. Use of a device without informed consent.

C. An unanticipated adverse device effect. The investigator notifies the sponsor and IRB within 10 days of notification of any unanticipated adverse effect. 21 CFR 812.150.

All of the following are requirements of an IRB EXCEPT that it: A. Is composed of at least five members B. Includes at least one non-scientific member C. Obtains informed consent from all subjects D. Represents the cultural mix of the community

C. Obtains informed consent from all subjects It is the responsibility of the clinical investigator to obtain informed consent from all subjects, not the IRB per 21 CFR 312.60. IRB composition is covered by 21 CFR 56.107. 45 CFR 46.

All of the following are requirements of an IRB EXCEPT that it: A. Is composed of at least five members. B. Includes at least one non-scientific member. C. Obtains informed consent from all subjects. D. Represents the cultural mix of the community.

C. Obtains informed consent from all subjects. It is the responsibility of the clinical investigator to obtain informed consent from all subjects, not the IRB. 21 CFR 312.60.

The Approved Drug Products with Therapeutic Equivalence Evaluations is commonly known as the A. Blue Book B. Pink Book C. Orange Book D. Green Book

C. Orange Book

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) enacted all the following EXCEPT: A. User fees for premarket reviews B. Office of Combination Products C. PDUFA renewal for five additional years D. New regulatory requirements for reprocessing single-use devices

C. PDUFA renewal for five additional years PDUFA was initiated/reauthorized under FDAMA. Also, the Prescription Drug User Fee Act would not be renewed under an act written for regulation of medical devices.

Procedures for identifying the control number for each unit, lot or batch of finished devices is required for which type of medical device? A. Surgical gloves B. X-ray machines C. Pacemakers D. Syringes

C. Pacemakers According to 21 CFR 820.65, "Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components." The Pacemaker is a Class III implantable device and is subject to 21 CFR 820.65. Regulatory Reference: 21 CFR 820.65 Traceability

GMP is required for both commercial and clinical materials including Phase 1 True or False

TRUE

In the late 1995 the requirement for lot release for biotech drugs identified as "well-characterized" was eliminated: True or False

TRUE

During the performance of a Class II product recall, additional complaint reports of the same product problem involved in the recall were received for products that were not in the date range of the product lots being recalled. What action should the regulatory professional recommend to the company? A. Discontinue the recall until they can determine the actual range of affected product B. Revise the recall scope and notify FDA within two business days about the additional reports and the revised recall scope C. Reassess the root cause analysis, traceability data and rationale for the original recall range to determine why original assumptions were incorrect and notify FDA within 10 working days of the extended recall range D. Provide FDA with a second correction and removal report

C. Reassess the root cause analysis, traceability data and rationale for the original recall range to determine why original assumptions were incorrect and notify FDA within 10 working days of the extended recall range Reports regarding the extension of the recall range are required to be filed within 10 working days of receiving the additional reports. The manufacturer amends the originally filed report and does not file a new report. 21 CFR 806.10(d): If, after submitting a report under this part, a manufacturer or importer determines that the same correction or removal should be extended to additional lots or batches of the same device, the manufacturer or importer shall within 10-working days of initiating the extension of the correction or removal, amend the report by submitting an amendment citing the original report number assigned according to paragraph (c)(1) of this section, all of the information required by paragraph (c)(2), and any information required by paragraphs (c)(3) through (c)(12) of this section that is different from the information submitted in the original report. The manufacturer or importer shall also provide a statement in accordance with paragraph (c)(13) of this section for any required information that is not readily available.

During the performance of a Class II product recall, additional complaint reports of the same product problem involved in the recall were received for products that were not in the date range of the product lots being recalled. What action should the regulatory professional recommend to the company? A. Dsicontinue the recall until they can determine the actual range of affected product. B. Revise the recall scope and notify FDA within two business days about the additional reports and the revised recall scope. C. Reassess the root cause analysis, traceability data and rationale for the original recall range to determine why original assumptions were incorrect and notify FDA within 10 working days of the extended recall range. D. Provide FDA with a second correction and removal report.

C. Reassess the root cause analysis, traceability data and rationale for the original recall range to determine why original assumptions were incorrect and notify FDA within 10 working days of the extended recall range.

The clinical research department has identified a new indication for one of the company's marketed drugs based on efficacy in preclinical models. The formulation for the drug product and the route of administration would be different. As the regulatory affairs professional, you should set up a meeting to discuss the regulatory path forward with which of the following departments in your company? A. Only the regulatory department is needed to decide the regulatory path forward. B. Regulatory, clinical and toxicology departments. C. Regulatory, clinical, toxicology, manufacturing and marketing departments. D. Regulatory, clinical, toxicology, manufacturing, marketing and shipping and receiving departments.

C. Regulatory, clinical, toxicology, manufacturing and marketing departments. Input from a number of key departments is needed to decide what GLP toxicology and clinical studies, manufacturing/formulation activities and resources would be necessary for this project and if pursuing the project is feasible from a marketing perspective Regulatory for regulatory path Clinical for new indication Toxicology for route of administration Manufacturing for new dose form Marketing for sale

A company's Phase 3 investigational drug product, available in three different tablet strengths, is a rapidly dissolving, immediate release, white, film-coated tablet. For the commercial drug product, the marketing division proposed distinguishing different strengths by using three different colors. What needs to be done to support this change in the drug product appearance? A. A bioequivalence study B. Multi-point in vitro dissolution profiles C. Release and stability testing of the proposed formulation against the specification established for white tablets D. Formulation changes are not acceptable after Phase 3 studies

C. Release and stability testing of the proposed formulation against the specification established for white tablets Adding a colorant to the tablet film coat is considered a minor change in the drug product formulation. Release and stability data for the proposed formulation meeting a specification established for the current formulation will be sufficient. However, the company should evaluate specificity of HPLC method for impurities and make sure colorants do not interfere with the separation of impurities.

A company's Phase 3 investigational drug product, available in three different tablet strengths, is a rapidly dissolving, immediate release, white, film-coated tablet. For the commercial drug product, the marketing division proposed distinguishing different strengths by using three different colors. What needs to be done to support this change in the drug product appearance? A. A bioequivalence study B. Multi-point in vitro dissolution profiles C. Release and stability testing of the proposed formulation against the specification established for white tablets D. Formulation changes are not acceptable after Phase 3 studies

C. Release and stability testing of the proposed formulation against the specification established for white tablets Adding a colorant to the tablet film coat is considered a minor change in the drug product formulation. Release and stability data for the proposed formulation meeting a specification established for the current formulation will be sufficient. However, the company should evaluate specificity of HPLC method for impurities and make sure colorants do not interfere with the separation of impurities.

A pharmaceutical company received approval of a drug that contains a boxed warning. What type(s) of advertisements are NOT permitted? A. Published journals and newspapers B. Radio and television C. Reminder advertisements D. Internet advertisements

C. Reminder advertisements Answer C is correct because reminder advertising is not permitted for drugs with boxed warnings since the boxed warning must be present on all advertising. From FDA: "Reminder ads give the drug's name but not the drug's use. The assumption behind reminder ads is that the audience knows what the drug is for and does not need to be told. A reminder ad does not contain risk information about the drug because the ad does not discuss the condition treated or how well the drug works. Reminder ads are not appropriate for drugs whose labeling has a "boxed warning" about certain very serious drug risks."

The following is exempt from the requirements for providing a true statement of information in brief summary relating to side effects, contraindications and effectiveness: A. Broadcast advertising B. Professional labeling C. Reminder advertising D. Direct to consumer advertising

C. Reminder advertising A. All advertisements for any prescription drug as regulated under 21 CFR 202.1(e)(1) require providing a true statement of information in brief summary relating to side effects, contraindications and effectiveness. B. See Explanation A. C. Reminder advertisements are those advertisements which call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. 21 CFR 202.1(e)(2)(i). D. See explanation A.

The following is exempt from the requirements for providing a true statement of information in brief summary relating to side effects, contraindications and effectiveness of prescription drugs: A. Broadcast advertising B. Professional labeling C. Reminder advertising D. Direct-to-consumer advertising

C. Reminder advertising This is not required for this type advertisement. Refer to 21 CFR 202.1(e) (1) and (e)(2) for explanation.

The following is exempt from the requirements for providing a true statement of information in brief summary relating to side effects, contraindications and effectiveness: A. Broadcast advertising. B. Professional labeling. C. Reminder advertising. D. Direct-to-consumer advertising.

C. Reminder advertising. This is not required for this type advertisement. Refer to 21 CFR 202(e)(2) for explanation.

While reviewing complaint files for a drug-eluting stent, a single entity combination product, it was noticed that an adverse event had occurred and a patient was hospitalized for two additional days. Such an adverse event was a foreseeable event and the mechanical features of the stent contributed to the occurrence. As a regulatory professional, your decision regarding the adverse event report would be: A. Report to FDA in a 15 Day Alert Report B. No action is needed as ADE reporting is only required for serious and unexpected adverse events; this ADE is expected so no reporting is needed C. Report to FDA in Form 3500A (MDR) within 30 days D. Report to FDA within 7 calendar days

C. Report to FDA in Form 3500A (MDR) within 30 days Under Food, Drug, and Cosmetic Act Section 503(g) (1), assignment to a lead center is based upon the combination product's primary mode of action (PMOA). In this product the device has the PMOA. As a device it follows the MDR reporting requirements. 21 CFR 600.80, 21 CFR 803.20(c), 21 CFR 312.53 1 and 2 are postmarket reporting requirements for drugs. 4 is a reporting requirement for an IND.

While reviewing complaint files for a drug-eluting stent, a single entity combination product, it was noticed an adverse event had occurred and a patient was hospitalized for two additional days. Such an adverse event was a foreseeable event and the mechanical features of the stent contributed to the occurrence. As a regulatory professional, your decision regarding the adverse event reporting would be: A. Report to FDA in a 15 Day Alert Report B. No action is needed as ADE reporting is only required for serious and unexpected adverse events; this ADE is expected so no reporting is needed C. Report to FDA in Form 3500A (MDR) within 30 days of becoming aware of the event D. Report to FDA within seven calendar days of becoming aware of the event

C. Report to FDA in Form 3500A (MDR) within 30 days of becoming aware of the event Under FD&C Act Section 503(g) (1), assignment to lead center is based upon the combination product's primary mode of action (PMOA). In this product, the device has the PMOA. As a device it follows the MDR reporting requirements. Answers A and B are postmarket reporting requirements for drugs. Answer C is a reporting requirement for medical devices, 30-day reporting timeframe for serious adverse consequence. Answer 4 is an IND reporting requirement. Therefore, 3 is the correct answer.

While reviewing complaint files for a drug-eluting stent, a single combination product, it was noticed that an adverse event had occurred and a patient was hospitalized for two additional days. Such an adverse event was a foreseeable event and the mechanical features of the stent contributed to the occurrence. As a regulatory professional, your decision regarding the adverse event reporting would be: A. Report to FDA in a 15 Day Alert Report B. No action is needed as ADE reporting is only required for unexpected events C. Report to FDA in a Form 3500A MDR within 30 days of becoming aware of the event D. Report to FDA within seven calendar days of becoming aware of the event

C. Report to FDA in a Form 3500A MDR within 30 days of becoming aware of the event

When FDA declares a device from a 510(k) application to be Not Substantially Equivalent (NSE) and requires a PMA. What is the most practicable first option for a company at this stage? A. File a PMA immediately B. Petition CDRH to down-classify the device (de novo process) C. Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate D. Submit this product for approval in Europe

C. Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate. Although an NSE Letter places the devices into the PMA category, FDA allows a company to refile the 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate. Petition to down-classify the device is the option when there are no comparable predicate devices but the "most practical" option is to refile the 510(k). The other goal of this question is to inform the examinee that although an NSE Letter places the device into the PMA category, it does not mean FDA is asking for a PMA filing. Regulatory Reference: 21 CFR 807.100; FDA CDRH Learn Presentation: 510(k) Overview

A PMA requires, as one element, a "summary in sufficient detail that the reader may gain a general understanding of the data and information in the application." Which of the following must be included in the summary? A. Summary of advertising B. List of manufacturing site(s) C. Significant physical and performance characteristics D. Description of related devices/technology

C. Significant physical and performance characteristics C. This is required according to 21 CFR 814.20(b)(3).

Devices that are exempt from premarket notification are: A. All Class I devices B. Some Class I devices C. Some Class I devices and some Class II devices D. All Class I devices and some Class II devices

C. Some Class I devices and some Class II devices Regulatory Reference: 21 CFR Parts 862 -- 892

The following FDA submissions can be valid for a non-substantially equivalent device EXCEPT: A. Pre-Market Approval (PMA) application B. Investigational Device Exemption (IDE) application C. Special 510(k) Premarket Notification D. reclassification petition

C. Special 510(k) Premarket Notification A. An NSE device is automatically classified as Class III; Class III products can be legally marketed with an approved PMA. B. An NSE device is automatically classified as Class III; Class III products can obtain further safety and efficacy data through a clinical trial (IDE). C. An NSE device has been determined to not be substantially equivalent to any Class II device; therefore submitting another form of premarket notification is not appropriate. D. Certain NSE devices are eligible for submission of a reclassification etition, to downclassify this device to a Class I or II, from the automatic Class III incurred by virtue of being found SE. (Section 207 [FDAMA]; Section 513 [f][2] of the FDCA; 21 USC 360c[f][2]).

Which information is not required be included in an IND? A. A brief general description of the composition, manufacture, and control of any placebo used in a controlled clinical trial B. A summary of previous human experience with the investigational drug C. Statistical methods to be used in the analysis of phase II and III clinical trials D. A copy of all labels and labeling to be provided to each investigator

C. Statistical methods to be used in the analysis of phase II and III clinical trials See 21 CFR 312.23

Phase 2 clinical trials are being planned for a novel cancer drug. All the following are appropriate factors in the phase of the study EXCEPT? A. Enrollment of cancer patients B. Enrollment of healthy subjects C. Study of one or more indications D. Collection of efficacy data

C. Study of one or more indications

You receive an assignment to obtain a Special Protocol Assessment for a Phase 3 clinical trial of an investigational anti-TNF biologic for inflammatory bowel disease. You advise the clinical team and senior management as follows: A. Submit a request to FDA for a Special Protocol Assessment as an amendment to the IND after the clinical trial has started B. It is not possible to request a Special Protocol Assessment for this clinical trial since it is not a Phase 2 clinical trial, stability trial or carcinogenicity trial C. Submit a request to FDA for a Special Protocol Assessment as a separate IND amendment at least 90 days before the clinical trial is scheduled to begin D. Submit a request to FDA for a Special Protocol Assessment as an amendment to the IND and wait 45 days; if FDA does not raise objections, the Special Protocol Assessment status is automatically granted

C. Submit a request to FDA for a Special Protocol Assessment as a separate IND amendment at least 90 days before the clinical trial is scheduled to begin 90 days should be considered as the minimum time allowed between submission of the SPA and protocol start. Time must be allowed to resolve issues. An SPA will not be awarded by FDA after a study has started. CDER and CBER generally recommend that a sponsor submit a protocol intended for special protocol assessment to the agency at least 90 days prior to the anticipated start of the study.

A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product that varies from the Reference Listed Drug (RLD) in route of administration, dosage form or strength, but anticipates the labeling will be identical to that of the RLD. What process should be used to apply for that permission from FDA? A. Citizen Petition B. Pre-NDA Meeting C. Suitability Petition D. Notice of Opportunity for Hearing

C. Suitability Petition A Suitability Petition is a request for permission to submit an ANDA. Sec. 314.93 Petition to request a change from a listed drug. A person who wants to submit an abbreviated new drug application for a drug product which is not identical to a listed drug in route of administration, dosage form, and strength, or in which one active ingredient is substituted for one of the active ingredients in a listed combination drug, must first obtain permission from FDA to submit such an abbreviated application.

A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product that varies from the Reference Listed Drug (RLD) in route of administration, dosage form or strength, but anticipates the labeling will be identical to that of the RLD. What process should be used to apply for that permission from FDA? A. Citizen Petition B. Pre-NDA Meeting C. Suitability Petition D. Notice of Opportunity for Hearing

C. Suitability Petition A Suitability Petition is a request for permission to submit an ANDA. Sec. 314.93 Petition to request a change from a listed drug. (b) A person who wants to submit an abbreviated new drug application for a drug product which is not identical to a listed drug in route of administration, dosage form, and strength, or in which one active ingredient is substituted for one of the active ingredients in a listed combination drug, must first obtain permission from FDA to submit such an abbreviated application.

Good Manufacturing Practices (GMPs) are NOT applied to the chemical synthesis of an Active Pharmaceutical Ingredient (API) manufacturing process during: A. Drying of an intermediate compound B. Introduction of the starting material into the process C. Synthesis of the starting material D. Packaging of the API

C. Synthesis of the starting material For synthetic processes, the introduction of the starting material into the manufacturing process is known as the point at which GMPs are applied in the manufacture of an API. Synthesis of the starting material does not have to be completed under GMPs.

Which of the following ingredients is specifically NOT prohibited from use in all cosmetics per section 21 CFR 700.11 through 700.23? A. Mercury B. Vinyl chloride C. Tetrachlorocarbon propellants D. B and C

C. Tetrachlorocarbon propellants

You are assigned the task of obtaining an Orphan Drug Designation (ODD) for a novel investigational drug for new onset Type I diabetes mellitus. Which of the following is NOT among your points of consideration for this ODD application? A. The ODD application must be submitted for review to FDA Office of Orphan Products Development (OOPD) B. This investigational drug may qualify for ODD as new onset Type I diabetes mellitus may be a medically plausible disease subset under the Orphan Drug Act C. The ODD application must be submitted electronically to the OOPD through the FDA Electronic Submission Gateway (ESG) D. The scientific rationale and population prevalence are two areas of the ODD application that are most critically reviewed by FDA

C. The ODD application must be submitted electronically to the OOPD through the FDA Electronic Submission Gateway (ESG) Sponsors may send the submission directly to OOPD on physical media with a signed paper cover letter.

Which publication identifies the prescription and non-prescription drug products formally approved by the FDA on the basis of safety and efficacy? A. Handbook for Requesting Information and Records from the FDA B. The United States Pharmacopeia Drug Information C. The Orange Book D. The Blue Book

C. The Orange Book

You are a German-based device manufacturer whose device is packaged in Ireland and sold in the US through a US-based company. The 510(k) was writtten by a contract organization. The label of our product may indicated any of the following EXCEPT" A. The principle place of business in the US B. The packaging location address C. The address of the contractor who submitted the 510(k) D. The address of the distributor

C. The address of the contractor who submitted the 510(k) Regulatory Reference: FDCA 801(e)(i). Medical devices; name and place of business of manufacturer, packer or distributor. (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer or distributor.

You work for a German-based device manufacturer that packages the device in Ireland and sells the product in the US through a US-based company. The 510(k) was written by a contract organization. The label of your product may indicate any of the following EXCEPT: A. The principal place of business in the US B. The packaging location address C. The address of the contractor who submitted the 510(k) D. The address of the distributor

C. The address of the contractor who submitted the 510(k) The address of the submitting contractor need not be listed on the final labeling of the product.

A television advertisement you have been asked to review prior to release discusses the drug's benefits in detail for 25 seconds, and then names all the major side effects associated with the product in the last five seconds. You should advise that: A. The advertisement can be released "as is," since it lists all the major side effects B. The side effects should be presented more slowly, so as to take up equal time with the benefits C. The benefits and side effects of the drug should be presented with the same level of scope, depth and detail D. Information about side effects should be stated earlier in the advertisement

C. The benefits and side effects of the drug should be presented with the same level of scope, depth and detail An advertisement does not satisfy the requirement that it present a true statement of information if it does not present a fair balance between information relating to effectiveness and information relating to side effects and contraindications. Fair balance means the benefits and risks of a drug must be described with the same scope, depth and detail, not just be given equal time.

A company's supplier of the active drug substance for the company's OTC monograph drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in six months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change. B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location. C. The change does not have to be reported because it is an OTC monograph drug. D. An amendment to the OTC monograph should be filed.

C. The change does not have to be reported because it is an OTC monograph drug. As this is an OTC monograph product there would be no FDA administrative file to report the change to.

A company's supplier of the active drug substance for the company's OTC monograph drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in six months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change. B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location. C. The change does not have to be reported because it is an OTC monograph drug. D. An amendment to the OTC monograph should be filed.

C. The change does not have to be reported because it is an OTC monograph drug. As this is an OTC monograph product there would be no FDA administrative file to report the change to.

A company's supplier of the active drug substance for the company's OTC monograph drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in six months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change. B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location. C. The change does not have to be reported because it is in OTC monograph drug. D. An amendment to the OTC monograph should be filed.

C. The change does not have to be reported because it is an OTC monograph drug. As this is an OTC monograph product there would be no FDA administrative file to report the change to.

The supplier of the active drug substance for a company's OTC monograph drug product informs the company that it will be moving its production of the drug substance from the current plant to a new manufacturing plant in another state in six months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an Annual Report because the company will qualify the change and the supplier said the process and specifications will not change B. The change should be reported in a Pre-approval Supplement C. The change would be reported during the annual drug listing process D. An amendment to the OTC monograph should be filed

C. The change would be reported during the annual drug listing process Monograph drugs are not subject to Annual Reports or Preapproval Supplements. Nor is the supplier of an active drug substance prescribed by regulation (so a change to the monograph is not warranted). However, because the manufacturing API Drug Establishment number will change, this must be updated with FDA as part of the annual drug listing process.

The supplier of the active drug substance for a company's OTC monograph drug product informs the company that it will be moving its production of the drug substance from the current plant to a new manufacturing plant in another state in six months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an Annual Report because the company will qualify the change and the supplier said the process and specifications will not change B. The change should be reported in a Pre-approval Supplement C. The change would be reported during the annual drug listing process D. An amendment to the OTC monograph should be filed

C. The change would be reported during the annual drug listing process Monograph drugs are not subject to Annual Reports or Preapproval Supplements. Nor is the supplier of an active drug substance prescribed by regulation (so a change to the monograph is not warranted). However, because the manufacturing API Drug Establishment number will change, this must be updated with FDA as part of the annual drug listing process.

During a periodic visit to a clinical investigator, the study monitor should assure all of the following EXCEPT: A. Informed consent has been documented in subject records B. The study protocol is being followed C. The investigator has assigned activities in the protocol to other staff D. Changes to the protocol have been approved by the IRB

C. The investigator has assigned activities in the protocol to other staff

You are the final distributor for a device that is subject to device tracking requirements. You are required to report information to aid in the tracking to: A. FDA B. Customs Authorities C. The manufacturer D. The hospital in which the device will be used

C. The manufacturer "A final distributor, upon sale or other distribution of a tracked device for use in or by the patient, shall promptly provide the manufacturer tracking the device with the following information..."

You are the final distributor for a device that is subject to device tracking requirements. You are required to report information to aid in the tracking to: A. FDA B. Customs Authorities C. The manufacturer D. The hospital in which the device will be used

C. The manufacturer "A final distributor, upon sale or other distribution of a tracked device for use in or by the patient, shall promptly provide the manufacturer tracking the device with the following information..."

A firm received a raw material for one of its drug products. The raw material was placed in quarantine and sampled appropriately. Sample containers should be identified so the following information can be determined: A. The manufacturer name, lot number, name of person who collected the sample and the date on which the sample was taken. B. The manufacturer name, lot number, the sample attributes, name of person who collected the sample and the date on which the sample was taken. C. The material name, lot number, the container from which the sample was taken, name of person who collected the sample and the date on which the sample was taken. D. The material name, lot number, sample attributes and the date on which the sample was taken.

C. The material name, lot number, the container from which the sample was taken, name of person who collected the sample and the date on which the sample was taken. Sample containers shall be identified so the following information can be determined: material name, lot number, the container from which the sample was taken, name of person who collected the sample and the date on which the sample was taken.

24. A firm received a raw material for one of its drug products. The raw material was placed into quarantine and samples appropriately. Sample containers should be identified so that the following information can be determined: A. The manufacturer name lot number name of person who collected the sample, and the date on which the sample was taken B. The manufacturer, the lot number, the sample attributes, name of person that collected the sample, and the date on which the sample was taken C. The material name, lot number, the container from which the sample was taken, name of person who collected the sample, and the date on which the sample was taken D. The material name, lot number, sample attributes, and the date on which the sample was taken

C. The material name, lot number, the container from which the sample was taken, name of person who collected the sample, and the date on which the sample was taken

In reviewing a single-dose protocol for an oral dosage in vivo bioequivalence study on 48 subjects, the regulatory affairs practitioner would make which of the following recommendations? A. Three different batches of both the drug and reference products should be used, each on eight patients B. A laboratory batch of at least 5,000 tablets may be used if it meets all final product specifications C. The study should be crossover in design and should provide for a drug elimination period D. The study should be conducted in three separate locations to minimize demographic differences

C. The study should be crossover in design and should provide for a drug elimination period A. This has too many parameters, too few patients per lot and no crossover control. B. Size of the laboratory batch is irrelevant to study design. C. Crossover uses patients as their own controls and the elimination phase prevents carryover effect from previous dose. 21 CFR 320.26. D. This has too many unnecessary parameters and has no crossover control.

In reviewing a single-dose protocol for an oral dosage in vivo bioequivalence study on 48 subjects, the regulatory affairs practitioner would make which of the following recommendations? A. Three different batches of both the drug and reference products should be used, each on 8 patients. B. A laboratory batch of at least 5,000 tablets may be used if it meets all final product specifications. C. The study should be crossover in design and should provide for a drug elimination period. D. The study should be conducted in 3 separate locations to minimize demographic differences.

C. The study should be crossover in design and should provide for a drug elimination period. A This has too many parameters, too few patients per lot and no crossover control. B. Size of the laboratory batch is irrelevant to study design. C. Crossover uses patients as their own controls and the elimination phase prevents carryover effect from previous dose. 21 CFR 320.26 · D. This has too many unnecessary parameters and has no crossover control.

During a periodic visit to a clinical investigator, the study monitor should assure all of the following EXCEPT: A. Informed Consent has been documented in subject records B. The study protocol is being followed C. The subjects are satisfied with the treatment they receive D. Changes to the protocol have been approved by the Institutional Review Board

C. The subjects are satisfied with the treatment they receive

After an inspection, FDA inspector will issue a FDA-483 (Inspectional Observations) due to the following? A. Always issue to summarize the inspection B. There is no observed deficiencies C. There is observed deficiencies D. The FDA inspector does not issue FDA-483. FDA-482 (Notice of Inspection) is issued after inspections

C. There is observed deficiencies

Which of the following statements is TRUE for Phase 2 clinical investigations of a previously untested drug? A. They are designed to determine the metabolism and pharmacologic actions of the drug in humans. B. They are intended to gather additional information about effectiveness and safety to evaluate the overall benefit-risk of the drug. C. They are conducted to determine the common short-term side effects and risks associated with the drug. D. They are performed to provide an adequate basis for physician labeling.

C. They are conducted to determine the common short-term side effects and risks associated with the drug. Answer C is true for Phase 2 studies Answer A is true for Phase 1 studies Answers B and D are true for Phase 3 studies.

A manufacturing process requires purified water to produce several finished Class I exempt and Class II 510(k) medical devices. The water is tested monthly by quality control. Since results have consistently been within specifications, the product is sent to distributors before QC results are final. Over the past six months, quality test results have been getting closer to the specification limit. Internal review determined that QC testing should now take place weekly. This information should be provided to FDA through: A. A postapproval study report B. A medical device report C. This information does not need to be submitted D. An Annual Report

C. This information does not need to be submitted As per CFR 820.70 (b), b)Production and process changes. Each manufacturer shall establish and maintain procedures for changes to a specification, method, process or procedure. Such changes shall be verified or, where appropriate, validated according to 820.75, before implementation and these activities shall be documented. Changes shall be approved in accordance with 820.40.

A manufacturing process requires purified water to produce several finished Class I exempt and Class II 510(k) medical devices. The water is tested monthly by quality control (QC). Since results have consistently been within specifications, the product is sent to distributors before QC results are final. Over the past six months quality test results have been getting closer to the specification limit. Internal review determined that QC testing should now take place weekly. This information should be provided to FDA through: A. A postapproval study report B. A medical device report C. This information does not need to be submitted D. An Annual Report

C. This information does not need to be submitted Regulatory Reference: 510(k) Memorandum #K97-1 Deciding When to Submit a 510(k) for a change to an existing device. Changes that require review for 510(k) notification include: o Technology/performance changes o Operating principle changes o Material changes o Labeling changes * This scenario does not meet any of these criteria

Your company has received approval for an extended-release tablet and can't keep up with demand. You will need to increase manufacturing capacity. Your company has another manufacturing site with a greater capacity for manufacture of this type of product. Which of the following departments would not be included in the project of transferring manufacturing operations for this product to the new site? A. Manufacturing B. Quality Assurance C. Toxicology D. Clinical

C. Toxicology Manufacturing and Quality Assurance are all involved in postapproval manufacturing changes. Clinical is involved because it is a manufacturing site change for a modified release dosage form. This would require a comparative bioavailability study or appropriate waiver. Toxicology would not be involved because the strength, dosage form, dosage regimen and route of administration would be unchanged.

Your company has received approval for an extended-release tablet and can't keep up with demand. You will need to increase manufacturing capacity. Your company has another manufacturing site with a greater capacity for manufacture of this type of product. Which of the following departments would not be included in the project of transferring manufacturing operations for this product to the new site? A. Manufacturing B. Quality Assurance C. Toxicology D. Clinical

C. Toxicology Manufacturing and Quality Assurance are all involved in postapproval manufacturing changes. Clinical is involved because it is a manufacturing site change for a modified release dosage form. This would require a comparative bioavailability study or appropriate waiver. Toxicology would not be involved because the strength, dosage form, dosage regimen and route of administration would be unchanged.

The supply chain organization would like to qualify an alternate vendor for the drug substance utilized to manufacture a drug product. Which question does NOT need to be asked in order to complete a regulatory assessment? A. Are the drug substance specifications changing? B. Does the vendor have a US DMF for this material? C. Where is the vendor located? D. Has the site had a satisfactory GMP inspection by FDA?

C. Where is the vendor located? To assess the regulatory impact and filing classification for this change, the answers for questions A, B and D are all beneficial to the regulatory professional. Although certain regions of the world have received additional attention from FDA, the location of the vendor is not needed to conduct the analysis.

Your company would like to convene a Type C meeting to discuss incorporating a new manufacturing process technique into your approved product. Once a request is sent to FDA, within what time frame should the meeting occur? A. Within 30 days of the agency's receipt of the meeting request. B. Within 60 days of the agency's receipt of the meeting request. C. Within 75 days of the agency's receipt of the meeting request. D. Within 15 days of the agency's receipt of the meeting request.

C. Within 75 days of the agency's receipt of the meeting request. Type C meetings should be scheduled to occur within 75 days of the agency's receipt of the written request for a meeting.

A clinical trial for a new treatment is recruiting study subjects and wants to use a posting on the company Facebook page to solicit participants. Does this information need IRB review? A. No Facebook and other social media programs are not within the jurisdiction of an IRB B. No not unless it appears after the study has started. C. Yes Advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study requires IRB approval D. Yes but only if the study is required to appear on the NCI cancer clinical trial listing (PDQ) or the government sponsored AIDS Clinical trial information services (ACTIS)

C. Yes Advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study requires IRB approval

Company ABC has requested orphan drug designation for their product. The product is currently in clinical trials for a rare disease for which the prevalence is approximately 100,000 individuals. The product was previously approved for another indication for which the prevalence is approximately one million individuals. Would the company be eligible for orphan drug designation for the rare disease and why? A. No, orphan designation cannot be granted on products previously approved B. Yes, orphan designation can be granted because the product is currently approved C. Yes, orphan designation can be granted because it is for a different indication than the indication currently marketed D. No, orphan designation cannot be granted because the product is currently approved

C. Yes, orphan designation can be granted because it is for a different indication than the indication currently marketed

Company ABC has requested orphan drug designation for its product. The product is currently in clinical trials for a rare blood disease for which the prevalence is approximately 100,000 individuals. The product previously approved for another indication for which the prevalence is approximately one million individuals. Would the company be eligible for orphan drug designation for the rare blood disease and why? A. No, orphan designation cannot be granted on products previously approved B. Yes, orphan designation can be granted because the product is approved C. Yes, orphan designation can be granted because it is for a different indication than the indication currently marketed D. No, orphan designation cannot be granted because the product is currently approved

C. Yes, orphan designation can be granted because it is for a different indication than the indication currently marketed A sponsor may request orphan drug designation of a previously unapproved drug, or for a new orphan indication for an already marketed drug. In addition, a sponsor of a drug that is otherwise the same drug as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent drug for the same rare disease or condition if it can present a plausible hypothesis that its drug may be clinically superior to the first drug.

Company ABC has requested orphan drug designation for its product. The product is currently in clinical trials for a rare blood disease for which the prevalence is approximately 100,000 individuals. The product previously approved for another indication for which the prevalence is approximately one million individuals. Would the company be eligible for orphan drug designation for the rare blood disease and why? A. No, orphan designation cannot be granted on products previously approved B. Yes, orphan designation can be granted because the product is approved C. Yes, orphan designation can be granted because it is for a different indication than the indication currently marketed D. No, orphan designation cannot be granted because the product is currently approved

C. Yes, orphan designation can be granted because it is for a different indication than the indication currently marketed A sponsor may request orphan drug designation of a previously unapproved drug, or for a new orphan indication for an already marketed drug. In addition, a sponsor of a drug that is otherwise the same drug as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent drug for the same rare disease or condition if it can present a plausible hypothesis that its drug may be clinically superior to the first drug.

ABC company will be using an investigational drug product for Phase 1 clinical studies that include SAD, MAD, food effect and drug-drug-interaction studies. The investigational drug product has a potential genotoxic impurity that is currently controlled at the level of exposure of NMT 10 µg/day. After completion of Phase 1 studies, the drug is planned to be reformulated into a different dosage form and re-evaluated for safety and quality. Is the current investigational drug acceptable for Phase 1 studies? A. No, since it has a potential genotoxic impurity B. No, since the potential genotoxic impurity is above the recommended 1.5 µg/day exposure C. Yes, since duration of all indicated clinical studies is less than six months D. Yes, since it will be used in investigational studies only

C. Yes, since duration of all indicated clinical studies is less than six months Acceptable qualification thresholds of genotoxic impurities during clinical development are based on the drug`s daily intake and duration of the studies. Phase 1 clinical studies are normally short-term, single-dose studies and last no longer than 14 days (with an exception for MAD that can run longer). The 10 µg/day daily intake of genotoxic impurity can qualify up to six months. Therefore, the use of this investigational drug product for a Phase 1 study is okay. However, for longer clinical studies and commercial drug product, the company should run qualification studies or reduce the threshold to NMT 1.5 µg/day.

ABC company will be using an investigational drug product for Phase 1 clinical studies that include SAD, MAD, food effect and drug-drug-interaction studies. The investigational drug product has a potential genotoxic impurity that is currently controlled at the level of exposure of NMT 10 μg/day. After completion of Phase 1 studies, the drug is planned to be reformulated into a different dosage form and re-evaluated for safety and quality. Is the current investigational drug acceptable for Phase 1 studies? A. No, since it has a potential genotoxic impurity B. No, since the potential genotoxic impurity is above the recommended 1.5 μg/day exposure C. Yes, since duration of all indicated clinical studies is less than six months D. Yes, since it will be used in investigational studies only

C. Yes, since duration of all indicated clinical studies is less than six months Acceptable qualification thresholds of genotoxic impurities during clinical development are based on the drug`s daily intake and duration of the studies. Phase 1 clinical studies are normally short-term, single-dose studies and last no longer than 14 days (with an exception for MAD that can run longer). The 10 μg/day daily intake of genotoxic impurity can qualify up to six months. Therefore, the use of this investigational drug product for a Phase 1 study is okay. However, for longer clinical studies and commercial drug product, the company should run qualification studies or reduce the threshold to NMT 1.5 μg/day.

A sponsor has an approved product that has been marketed for several years and contains a preservative. However, the product has been reformulated to remove the preservative and the sponsor conducted new clinical trials essential to support approval of the new application. Does the sponsor qualify for exclusivity for the product? A. No, the sponsor does not qualify for exclusivity. B. Yes, the sponsor qualifies for 180-day exclusivity. C. Yes, the sponsor qualifies for three-year exclusivity. D. Yes, the sponsor qualifies for five-year exclusivity.

C. Yes, the sponsor qualifies for three-year exclusivity. The Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984) provides for patent term extensions. Under the amendment to the FD&C Act, a sponsor may qualify for three-year exclusivity if the following criteria are met: the active moiety must have been the subject of an approved application, the new application (defined as a full NDA, BLA, 505(b)(2) or a supplement to any application mentioned) must contain new clinical trial data that are essential to support the approval of the new application, and the clinical trials must be conducted by the applicant.

A firm can best ensure the effectiveness of a drug, device or biologic recall by which of the following? A. confirmation of receipt of recall notification B. return of the recalled product from distribution C. accurate accountability of the recalled product D. completion of FDA recall effectiveness checks

C. accurate accountability of the recalled product A Recall notification receipt does not provide information on disposition of the product. B. All of available recalled product may not be returned or be required to be returned depending on recall class. C. A determination of product status, regardless of whether product is returned, provides the best accounting for all recalled products. 21 CFR part 7.42(b)(3), FDA Regulatory Procedures Manual, Chapter 7, p. 272 D. Primary responsibility for effectiveness checks rests with the recalling firm. FDA recall effectiveness checks may cover only a statistical number of accounts and do not necessarily result in product accountability.

Under the IDE regulation, all of the following must be reported to the sponsor within five days EXCEPT: A. a deviation from the investigational plan B. withdrawal of IRB approval C. an unanticipated adverse device effect D. use of a device without informed consent

C. an unanticipated adverse device effect A. The investigator should notify the sponsor within five days. B. Withdrawal of IRB approval is reported within five days. C. The investigator notifies the sponsor and IRB within 10 days of notification of any unanticipated adverse effect. 21 CFR 812.150. D. The investigator reports to the sponsor and IRB within five days after this occurs.

Under the IDE regulation, all of the following must be reported to the sponsor within 5 days EXCEPT: A. a deviation from the investigational plan. B. withdrawal of IRB approval. C. an unanticipated adverse device effect. D. use of a device without informed consent.

C. an unanticipated adverse device effect. A. The investigator should notify the sponsor within 5 days. B. Withdrawal of IRB approval is reponed within 5 days. C. The investigator notifies the sponsor and IRB within 10 days of notification of any unanticipated adverse effect. 21 CFR 812.150 D. The investigator reports to the sponsor and IRB within 5 days after this occurs.

FDA wants to discuss a new voluntary user reporting experience program for genetically cloned products (food, drugs, cosmetics, in-vitro diagnostics). Initially, the best way for FDA to obtain industry input for the preparation of a first draft is to: A. publish an article in Regulatory Affairs Focus B. announce a public hearing on the issue C. conduct talks with a number of trade associations D. issue a Federal Register notice of intent to promulgate a guideline

C. conduct talks with a number of trade associations A. This is not the most effective way to reach the desired audience. B. This is premature at this stage. C. This is most effective to obtain industry input at this time. D. See explanation B.

FDA wants to discuss a new voluntary user-reporting experience program for genetically cloned products (food, drugs, cosmetics, in-vitro diagnostics). Initially, the best way for FDA to obtain industry input for the preparation of a first draft is to: A. publish an article in the RAPS Regulatory Affairs Focus. B. announce a public hearing on the issue. C. conduct talks with a number of trade associations. D. issue a Federal Register notice of intent to promulgate a guideline.

C. conduct talks with a number of trade associations. A. This is not the most effective way to reach the desired audience. B. This is premature at this stage. C. This is most effective to obtain industry input at this time. D. This is premature at this stage.

QSR/GMP requirements apply to all of the following EXCEPT: A. finished devices intended for human use manufactured in the US B. finished devices imported or offered for import C. device components manufactured in the US D. critical devices, either manufactured or imported

C. device components manufactured in the US A. Manufacturers of finished devices must comply with GMP. B. Medical devices which are imported or offered for import into the US are required to have been manufactured under GMP. C. Manufacturers of components or parts of finished devices are encouraged, but not required to follow GMP. 21 CFR 820.1. D. Critical device manufacturers and importers are required to follow GMP.

To avoid the potential for cross-contamination, FDA requires the manufacture of penicillin products to be: A. in a building separated from other manufacturing buildings B. in plants that are inspected quarterly C. in a dedicated and validated isolation facility D. under laminar flow protection that is validated periodically

C. in a dedicated and validated isolation facility A. This is not sufficient to assure no cross-contamination. B. See explanation A. C. GMP requires dedicated facilities for penicillin manufacture. 21 CFR 211.42(d), 211.46(d). D. See explanation A.

To avoid the potential for cross-contamination, FDA requires the manufacture of penicillin products to be: A. in a building separated from other manufacturing buildings. B. in plants that are inspected quarterly. C. in a dedicated and validated isolation facility. D. under laminar flow protection that is validated periodically.

C. in a dedicated and validated isolation facility. A. This is not sufficient to assure no cross-contamination. B. See explanation A C. GMP requires dedicated facilities for penicillin manufacture. 21 CFR 211.42(d), 211.46(d) D. See explanation A

Removal of a distributed product for a reason NOT subject to legal action by FDA is known as: A. product recall. B. stock recovery. C. market withdrawal. D. corrective action.

C. market withdrawal. A. This term applies when a product is considered in violation of the law and the agency can initiate legal action. 21 CFR 7.3(g). B. This term applies when a firm removes or corrects a product that has not been marketed or has not left the direct control of the firm. 21 CFR 7.3(k). C. This term applies when FDA considers a firm's action of product removal or correction of a distributed product. It is a minor violation or no violation and not subject to legal action. 21 CFR 7.3(j). D. This term applies when repair or modification of a product occurs without its physical removal to another location. 21 CFR 7.3(h).

All of the following are requirements of an IRB, EXCEPT that it: A. has at least five members B. includes at least one nonscientific member C. obtains informed consent from all subjects D. represents the cultural mix of the community

C. obtains informed consent from all subjects A. It is a requirement that each IRB have at least five members. 21 CFR 56.107(a). B. The regulations require each IRB to have at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas. 21 CFR 56.107(c). C. It is the responsibility of the clinical investigator to obtain informed consent from all subjects, not the IRB. 21 CFR 312.60. D. The regulations require each IRB to have a diversity of members, including consideration of race, gender and cultural backgrounds, who will have sensitivity to community attitudes. 21 CFR 56.107(a).

A legally marketed device to which equivalence is drawn in a premarketing submission is known as the: A. market comparator device B. placebo device C. predicate device D. substantially equivalent device

C. predicate device A. Terminology not used by CDRH. B. Terminology not used by CDRH. C. 21 CFR 807.92(a)(3) and 21 CFR 807.100(b). D. "Substantially equivalent" or "not substantially equivalent" are declarations applied to the device that is subject of the submission. 21 CFR 801.100(a)(j) or 21 CFR 807.100(a)(1)(2)

A product storage and handling system for medical devices must include: A. procedures for rotation of stock B. separate rooms or cages for release and quarantine products C. procedures for receipt and transfer of product D. environmentally controlled areas for products with shelf life

C. procedures for receipt and transfer of product A. Procedures for rotation of stock are required only when quality will deteriorate over time. B. Separate rooms or cages are not mandated. C. Procedures for receipt and transfer of products are required. A medical device handling and storage system must have procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms. D. Environmentally controlled areas are required only when environmental conditions could reasonably be expected to have an adverse effect on quality.

In conformance with GMP, which of the following departments is responsible for approving or rejecting final products? A. regulatory affairs B. quarantine and inspection C. quality control D. operations

C. quality control A. This department does not have this responsibility or authority. B. See explanation A. C. QC has the responsibility and authority to approve or reject final products, 21 CFR 211.22. Establishmentof a Quality system is a requirement for QSR, 21 CFR 820.5, 820.20, 820.22, 820.80. Additional information is available in Medical Device Quality Systems Manual: A Small Entity Compliance Guide. GTPs also mandate establishment of a Quality Program, 21 CFR 1271.160. D. See explanation A.

A PMA requires, as one element, a "summary in sufficient detail that the reader may gain a general understanding of the data and information in the application. " Which of the following must be included in the summary? A. summary of advertising B. list of manufacturing site(s) C. significant physical and performance characteristics D. description of related devices/technology

C. significant physical and performance characteristics This is required according to 21 CFR 814.20(b)(3).

Where the established name is required to accompany or be used in association with the proprietary name or designation, all of the following are true EXCEPT: A. the established name shall be placed in direct conjunction with the proprietary name or designation B. the established name shall be printed in letters that are at least half as large as the letters comprising the proprietary name or designation with is joined C. the established name shall be printed in letters that are at least 1⁄4 as large as the letters compromising the proprietary name or designation D. the established name shall have a prominence commensurate with the prominence with which such proprietary name or designation appears

C. the established name shall be printed in letters that are at least 1⁄4 as large as the letters compromising the proprietary name or designation A. This is true under 21 CFR 202.1(b)(1). B. This is true under 21 CFR 202.1(b)(2). C. False. 21 CFR 202.1(b)(2). D. This is true under 21 CFR 202.1(b)(2).

For an IVD to be cleared under a traditional 510(k), a product sponsor must prove to FDA that A. the new device has the same intended use as a previously cleared device B. the new device has the same intended use as a previously approved device C. the new device is substantially equivalent to a previously cleared device D. the new device improves on the technology of a previously cleared device

C. the new device is substantially equivalent to a previously cleared device

A new device undergoes design review. The review determines that current analytical data do not provide enough information to move ahead with human testing. A decision is made to discard the data and being a new study with the same protocol. This is an acceptable approach if: A. The intended use of the product does not change B. The original data are destroyed before new testing starts C. the original data are stored in the device deign history file D. The new study tests three times as many samples as the ole one.

C. the original data are stored in the device deign history file 21 CFR 820.30 (e) Design review - Each manufacturer shall establish...that formal documented reviews...are planned and conducted. ...the results of the design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file. 820.30(f)...The results of the design verification, including identification of the design, method(s), the data, and the individual(s) performing the verification, shall be documented in the DHF. Regulatory Reference: 21 CFR 820.30 Design Controls; 820.30(f) DHF.

Which of the following types of information from a Summary Basis of Approval is disclosable? A. adverse reaction reports including the name of the reporting physician or hospital B. manufacturing methods or processes C. written summaries of oral discussions between FDA and the applicant relating to the application D. written summaries of financial information relating to the applicant

C. written summaries of oral discussions between FDA and the applicant relating to the application A Information identifying any third party is not disclosable [per 314.430(e)(4)(ii)}. B. Manufacturing methods or processes are not disclosable. [314.4309(g)(l)] C. [per 314.430(e)(7)} D. Financial information is not disclosed to FDA

Which of the following types of information from a Summary Basis of Approval is disclosable? A. adverse reaction reports, including the name of the reporting institution B. manufacturing methods or processes C. written summaries of oral discussions between FDA and the applicant relating to the application D. production and sales distribution data

C. written summaries of oral discussions between FDA and the applicant relating to the application A. Information identifying any third party is not disclosable. 21 CFR 314.430(e)(4)(ii). B. Manufacturing methods or processes are not disclosable. 21 CFR 314.430 (g)(1). C. This is disclosable information. 21 CFR 314.430(e)(7). D. Production, sales distribution, and similar data and information are not disclosable. 21 CFR 314.430(g)(2).

A new device undergoes design review. The review determines current analytical data do not provide enough information to move ahead with human testing. A decision is made to discard the data and begin a new study with a different protocol. This is an acceptable approach if: A. The intended use of the product does not change. B. The original data are destroyed before new testing starts. C.The original data are stored in the device design history file. D. The new study tests three times as many samples as the old one.

C.The original data are stored in the device design history file. 21 CFR 820.30 (e) Design review—Each manufacturer shall establish...that formal documented reviews...are planned and conducted. ...the results of the design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file. 820.30(f)...The results of the design verification, including identification of the design, method(s), the data, and the individual(s) performing the verification, shall be documented in the Design History File (DHF). Design review refers to formal, systematic (i.e., conducted at planned intervals) reviews of the design verification results conducted at appropriate stages of the device's design development. The purpose of the review is to evaluate the adequacy of the design requirements and the capability of the design to meet these requirements, and to identify problems. The outcome of the design reviews, including identification of the design stage, the date and the individuals involved in the review, should be documented in the Design History File

Which of the following best describes Advisory Committee meetings? A) Advisory Committee meetings are always open to the public B) Advisory Committee meetings only occur in the product approval stage C) FDA must follow resulting recommendations of Advisory Committee D) Advisory Committee meetings are a way for FDA to consult with outside experts

D) Advisory Committee meetings are a way for FDA to consult with outside experts FDA's technical and scientific advisory committees are composed of outside experts, ie not FDA employees. The primary role of an advisory committee is to provide independent advice that will contribute to the quality of the agency's regulatory decision-making and lend credibility to the product review process. In this way, the FDA can make sound decisions about new medical products and other public health issues. And although advisory committees have a prominent role in the product approval stage, they are sometimes included earlier in the product development cycle and are asked to consider issues relating to products already on the market. Committees typically are asked to comment on whether adequate data supports approval, clearance,

According to the QSR, Document Controls apply to: A) Design History File (DHF) B) Device Master Record (DMR) C) Device History Record (DHR) D) All of the above

D) All of the above (e) Design history file (DHF) means a compilation of records which describes the design history of a finished device (i) Device history record (DHR) means a compilation of records containing the production history of a finished device (j) Device master record (DMR) means a compilation of records containing the procedure and specifications for a finished device

Which of the following convey "intended use" for a drug product? A) Prescribing information B) Verbal statements by sponsor or sponsor's representative about a product's use at a trade show C) Printed promotional materials D) All of the above

D) All of the above The intended use is what the product does, based on the objective intent of persons legally responsible for labeling Verbal statements, like at a trade show, or seminar can convey or change intended use. Likewise for promotional materials. This regulatory provision is not intended to restrict the full exchange of scientific information concerning the product, including dissemination of scientific findings in scientific or lay media FDA has not regulated and does not intend to regulate industry-supported scientific and educational activities that are independent of the influence of the supporting company. The key is whether the Continuing Medical Education (CME) activities are free from the supporting company's influence and bias

At completion of review of a 510(k), FDA may take the following actions except: A) Declare device substantially equivalent B) Declare device not substantially equivalent C) State a 510(k) is not required to market the device D) Approve the device for market

D) Approve the device for market 510(k) is for clearance to market not an approval

At completion of review of a 510(k), FDA may take the following actions except: A) Declare device substantially equivalent B) Declare device not substantially equivalent C) State a 510(k) is not required to market the device D) Approve the device for market

D) Approve the device for market FDA's response to a 510K submission is a marketing clearance letter. FDA does not approve, they determine that your product is substantially equivalent to currently marketed devices. Then they issue a CLEARANCE to market your product. FDA does approve your PMA but only assign substantial equivalence for a 510K AND clearance to market

According to GMP regulations, the quality control unit is responsible for which of the following activities: A) Issuing unique identification to all major manufacturing equipment B) Manufacturing drug products C) Warehousing and distributing drug products D) Approving and rejecting raw materials, components, label, drug products, procedures and specifications

D) Approving and rejecting raw materials, components, label, drug products, procedures and specifications

According to the QSR, personnel involved in the design, manufacture, distribution, servicing, and reporting must: A) Must hold a Master's degree or higher B) At a minimum receive procedure training once per year in their area of responsibility C) Be able to recite the Quality Policy, if asked D) Be made aware of defects which may occur if they do not perform their job correctly

D) Be made aware of defects which may occur if they do not perform their job correctly

According to the QSR, personnel involved in the design, manufacture, distribution, servicing, and reporting must: A) Must hold a Master's degree or higher B) At a minimum receive procedure training once per year in their area of responsibility C) Be able to recite the Quality Policy, if asked D) Be made aware of defects which may occur if they do not perform their job correctly

D) Be made aware of defects which may occur if they do not perform their job correctly Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

For a marketed product, which of the following is an example of a "Changes Being Effected-30 days" supplement? A) Deletion or reduction of an ingredient to affect color B) New analytical method C) Addition of an alternate analytical method D) Change in site of testing from one facility to another

D) Change in site of testing from one facility to another Changes being effected -Add/strengthen contraindication, warning, precaution, adverse reaction -Instruction about dose intended to increase safe use of product -Delete false or misleading, or unsupported indications, or claims of effectiveness Annual Report -Delete/reduce ingredient to affect color -Changes to comply with official compendium -Editorial change to label

You are developing a combination product and believe the primary mode of action will designate the product as a drug as opposed to a device. Your first course of action is to: A) Develop written rationale describing the product, mode(s) of action, and proposed classification as a drug B) Submit a formal request for designation to the Office of Combination Products C) Call the CDER review division D) Check the FDA website for information, eg, other combination/similar products

D) Check the FDA website for information, eg, other combination/similar products combination product, primary mode of action, you think drug, FIRST Best answer is D, check the FDA website. Lots of helpful information here. You can look at other combination products, similar products. If you needed to submit a formal request for designation, you'd need to write your rationale for what you believe is the appropriate classification. Then you'd submit your rationale with your request for designation.

Which of the following is not found in the Orange Book? A) Patent information for approved drug products B) Exclusivity information for approved drug products C) Information related to therapeutic equivalence for approved drug products D) Drug products approved on the basis of safety

D) Drug products approved on the basis of safety Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -Drug products approved on the basis of safety and effectiveness by FDA under the FD&C Act -Drugs on the market approved only on the basis of safety or pre-1938 drugs are not included in the Orange Book Therapeutic Equivalents -Drug products that are pharmaceutical equivalents AND -Have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling

Which of the following best represents the Quality Systems Inspection Technique? A) Focus on Manufacturing and Manufacturing Processes B) Focus on QC testing and Product Release C) Focus on Batch Record Review D) Focus on Management

D) Focus on Management Remembering that there is an FDA focus Moving closer to a Global Harmonization guideline for regulatory auditing of quality systems, think about reviewing the SYSTEM and what or who could or should have the most impact on the SYSTEM QSIT Theme #1 = Management -Management is responsible for Implementing Quality System -Start & Finish with Management -All product, process, design & CAPA problems can be tied to management

Which of the following is NOT a key Medical Device submission which directly leads to marketing permission from FDA? A) 510(k), Pre-market Notification, Part 807 B) HDE, Humanitarian Device Exemption, Part 814 C) Premarket Approval (PMA), Part 814 D) IDE, Investigational Device Exemptions, Part 812

D) IDE, Investigational Device Exemptions, Part 812 Your IDE is a permission to ship product for clinical trial use only. It is the mechanism to have an EXEMPTION to meeting the pre-market notification or pre-market approval requirements, in order to perform your clinical trials. IDE are a part of the process for product registrations that require clinical trial data, but the IDE does not directly lead to marketing permission. Remember from one of the early drug slides, Carol mentioned the IND application. An IND provides an exemption from premarketing approval requirements and allows you to legally ship drug to conduct the proposed clinical study. In the device world, an IDE investigation provides data to be used in your 510K or PMA, and in the drug/biologic world, an IND serves the same purpose for an NDA or BLA.

Which of the following is not an example of misbranding? A) An incorrect lot number on the label B) A drug product without a manufacturer, packer or distributor on the label C) Font size of established name is 25% of the font size of the trade name D) Lack of NDC on label

D) Lack of NDC on label NDC number not required on the label 21 CFR 201.2: NDC number requested but not required

Standard operating procedures should be generated for the following GLP activities except: A) Animal Care B) Laboratory Tests C) Data Handling, Storage and Retrieval D) Management of Publications

D) Management of Publications

As a regulatory affairs professional, you are provided evidence that your firm's product has been the subject of criminal tampering post-distribution which has resulted in two known deaths. You assemble the appropriate internal team in order to implement a: A) Class I Recall B) Class II Recall C) Class III Recall D) Market Withdrawal

D) Market Withdrawal product subject to criminal tampering post-distribution, ie, sponsor did not violate the law. Mentioning "2 known deaths" might have distracted you to pick Class 1 recall. Recall: Action taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. Product is viewed as being in violation of the law and FDA would initiate legal action such as seizure. -Class I recall: reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. -Class II recall: use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote -Class III recall: use of or exposure to a violative product is not likely to cause adverse health consequences -Market withdrawal: Firm's removal of a distributed product that involves no violation of the law by the manufacturer. -Examples: A product removed from the market due to tampering, without evidence of manufacturing or distribution problems or removal of product for purposes of stock rotation. Would not be subject to legal action by FDA. -Field correction: Repair, modification, adjustment, relabeling, of a product without physically removing it to another location

Which Congressional Act provided Statutory Authority to FDA to regulate medical devices? A) Safe Medical Devices Act of 1990 (SMDA) B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA) C) Federal Food, Drug, Cosmetic Act (FDC Act) D) Medical Device Amendments of 1976 (MDA)

D) Medical Device Amendments of 1976 (MDA)

Which Congressional Act provided Statutory Authority to FDA to regulate medical devices? A) Safe Medical Devices Act of 1990 (SMDA) B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA) C) Federal Food, Drug, Cosmetic Act (FDC Act) D) Medical Device Amendments of 1976 (MDA)

D) Medical Device Amendments of 1976 (MDA)

Written procedures (SOPs) for production and process control deviation must meet all the following criteria except: A) Must exist for production and process controls B) Must assure that the drug products have the identity, strength, quality and purity C) Must be reviewed and approved by the quality control unit D) Must be written by the production function

D) Must be written by the production function

Clinical protocol amendments are required for the following except: A) Increase in drug dosage or duration of subject exposure B) Addition of a test or procedure to monitor safety C) Significant change in protocol design D) Phase 1 study design changes that do not affect critical safety assessments

D) Phase 1 study design changes that do not affect critical safety assessments - this is an IND Annual Report requirement

Which of the following is a covered study as defined under Financial Disclosure regulations: A) Phase I dose escalation study B) Phase I/II Pharmacokinetic Study C) A large open label safety study conducted at a large number of study sites D) Phase III pivotal study

D) Phase III pivotal study Here, it is essential for you to know the definition of covered study, that is, a study submitted in a marketing application that FDA relies upon to establish the safety or efficacy of a product or situations where a single investigator makes a significant contribution to the demonstration of safety. Typically, Phase I studies, most clinical pharmacology studies and large open label safety studies at multiple sites are not covered studies.

Informed consent documentation must be compliant with all except the following: A) Signature of the subject or the subject's legal representative B) Revised due to new information regarding the investigational product that might affect a subject's willingness to participate in the study becomes available C) Approved by the clinical trial site IRB D) Revised due to change in contact person name and/or phone number

D) Revised due to change in contact person name and/or phone number

With respect to a Non-Significant Risk device clinical trial, which of the following is NOT required before starting the trial? A) Informed consent of trial participants B) IRB approval of the trial C) Financial disclosure by investigators D) Submission of the trial protocol to FDA for approval

D) Submission of the trial protocol to FDA for approval FDA approval not needed for NSR (Non-Significant Risk device) For studies not conducted under an FDA-approved IDE, (that is, a non-significant risk IDE or an exempt study), the sponsor would need to identify the investigators and sub-investigators they considered covered by the rule in form 3454 and 3455. We expect that there will be at least one such person at each site.

According to the QSR, Design Inputs are best described by the following: A) The Operator's Manual and instructions on how to use the device B) The Instructions For Use (IFU) of the device C) Marketing claims and features that are required for the device D) The performance requirements that the product must meet

D) The performance requirements that the product must meet

According to the QSR, Design Inputs are best described by the following: A) The Operator's Manual and instructions on how to use the device B) The Instructions For Use (IFU) of the device C) Marketing claims and features that are required for the device D) The performance requirements that the product must meet

D) The performance requirements that the product must meet Design input means the physical and performance requirements of a device that are used as the basis for device design.

The manufacturer of an approved prostate-specific antigen (PSA) test developed a new automated analyzer to perform the total PSA testing. There were no changes to the indications for use or technology of the test and no new clinical data were required. Only analytical testing was performed to demonstrate the new analyzer did not alter the performance of the assay. What kind of PMA supplement to the approved premarket application will be required for this change? A. Special PMA Supplements-Changes Being Affected B. 30 day Notice C. Real Time Supplement D. 180-Day Supplement

D. 180-Day Supplement This is a significant change to the PMA device and will require a 180-Day Supplement. "180-day supplement" is defined as: "a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling." per section C5 of the guidance. Special PMA Supplement—Changes Being Effected (CBE)—21 CFR 814.39(d) The CBE generally is used when the change enhances or increases the device's safety. It does not require FDA approval before making the change. Examples are labeling changes that add more relevant information and increased quality control testing. 30-Day Notice and 135-Day PMA Supplement—21 CFR 814.39(f) A 30-Day Notice is used for modifications to manufacturing procedures or methods that affect the device's safety and effectiveness. If FDA does not respond within 30 days after notification, the change can be made to the device and it can be marketed accordingly. If FDA finds the 30-Day Notice is not adequate, but contains data meeting appropriate content requirements for a PMA supplement, the 30-Day Notice will become a 135-Day PMA Supplement. Real Time PMA Supplement A supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.

The manufacturer of an approved prostate specific antigen (PSA) test developed a new automated analyzer to perform the total PSA testing. There were no changes to the indications for use or technology of the test and no new clinical data were required. Only analytical testing was performed to demonstrate the new analyzer did not alter the performance of the assay. What kind of PMA supplement to the approved premarket application will be required for this change? A. Special PMA Supplements-Changes Being Affected B. 30 day Notice C. Real Time Supplement D. 180-Day Supplement

D. 180-Day Supplement cation or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling." per section C5 of the guidance.

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of: 1. Class I devices 2. Class II devices 3. Class III devices A. 3 only B. 2 only C. 1 and 2 D. 2 and 3

D. 2 and 3 D. Class I devices are the least hazardous and are not the primary focus of FDA inspections. Third party inspections allow FDA to focus on higher-risk inspections.

A company is developing a demineralized bone matrix (DBM) product intended as a bone void filler. The DBM product consists of DBM manufactured from human allograft bone and a polymer gel to improve handling and containment of the DBM in the bone defect. The DBM product must comply with the following regulation(s): A. 21 CFR 210 and 211 B. 21 CFR 820 C. 21 CFR 1271 D. 21 CFR 1271 and 820

D. 21 CFR 1271 and 820 Demineralized bone matrix alone (i.e., not combined with another component) is an HCT/P which meets the four criteria to be regulated solely under Section 361 of the Public Health Service Act. FDA, however, has determined the addition of certain components to DBM, such as polymer gels or calcium phosphates, meets the definition of a device as they are intended to affect the structure or function of the body by assisting in the filling of bone voids. These DBM products, therefore, are regulated as devices by CDRH (510(k) clearance required) and as such must comply with 21 CFR 820 Quality System Regulation. In addition, the product also needs to comply with the requirements of 21 CFR 1271 Human Cells, Tissues and Cellular and Tissue-Based Products due to the human tissue component.

Which Premarket Approval Application (PMA) supplements are NOT subject to use fee exemption? A. Special PMA Supplements Changes Being Affected B. PMA Manufacturing Site Change Supplements C. Real Time Supplements D. 30 Day Notices 135 Day Supplements

D. 30 Day Notices 135 Day Supplements

A sponsor's drug development program has come to a standstill and is in need of a meeting with FDA. The company decides to schedule a meeting through an IND amendment. Within how many days of FDA receipt should the meeting be scheduled? A. 180 days B. 75 days C. 60 days D. 30 days

D. 30 days A Type A meeting is a meeting needed to help an otherwise stalled product development program proceed.These meetings, also known as "critical path" meetings, should be scheduled to occur within 30 days of FDA receipt of a written meeting request.

A sponsor's drug development program has come to a standstill and is in need of a meeting with FDA. The company decides to schedule a meeting through an IND amendment. Within how many days of FDA receipt should the meeting be scheduled? A. 180 days B. 75 days C. 60 days D. 30 days

D. 30 days A Type A meeting is a meeting needed to help an otherwise stalled product development program proceed.These meetings, also known as "critical path" meetings, should be scheduled to occur within 30 days of FDA receipt of a written meeting request.

When the manufacturer becomes aware of a death associated with the product, which of the following is the maximum time frame for submitting an MDR to FDA? A. immediately B. 5 days c. 15 days D. 30 days

D. 30 days A report must be ft.led within 30 days. 21 CFR 803.50(a)

When the manufacturer becomes aware of a death associated with the product, which of the following is the maximum time frame for submitting an MDR to FDA? A. Immediately B. Five days C. 15 days D. 30 days

D. 30 days D. A report must be filed within 30 days. 21 CFR 803.50(a).

If the FDA responds to a 510(k) with a NSE letter, the 510(k) applicant has which of the following options? A. Resubmit another 510(k) with additional data supporting the claim of SE B. Petition the FDA for reconsideration of its decision C. Claim exemption from 510(k) requirements D. A & B only

D. A & B only A. Resubmit another 510(k) with additional data supporting the claim of SE B. Petition the FDA for reconsideration of its decision

Five-year exclusivity on a chemical compound, sometimes called New Chemical Entity (NCE) exclusivity, prevents the approval of all of the following for five years EXCEPT: A. A generic application for the approved active ingredient B. A generic application for a salt of the approved active ingredient C. A generic application for an ester of the approved active ingredient D. A Section 505(b)(1) New Drug Application (NDA) for the same drug

D. A Section 505(b)(1) New Drug Application (NDA) for the same drug NCE exclusivity prevents the approval of a generic application for the approved active ingredient or any salt or ester of the approved active ingredient for five years. However, five-year exclusivity does not prevent FDA from approving, or a company from submitting, a full Section 505(b)(1) NDA for the same drug.

Which of the following sections is required in a PMA? A. Patent certification information B. A copy of quality manual C. An economic cost/benefit assessment D. A discussion of benefit and risk considerations

D. A discussion of benefit and risk considerations D. See 21 CFR 814.20(b)(3)(vi).

In routine stability testing of an NDA drug, a firm discovers a previously unidentified impurity at the 24-month checkpoint. The firm performs a laboratory investigation and the impurity results are confirmed. The drug product has a 36-month shelf life. What should happen next? A. A full investigation into the identification and safety of the impurity should commence. B. A full investigation into the source of the impurity should commence. C. CDER should be notified within 15 working days and a Class III recall should be initiated. D. A field alert report should be submitted to the FDA District Office within three working days of confirmation of the impurity.

D. A field alert report should be submitted to the FDA District Office within three working days of confirmation of the impurity. A field alert report form must be submitted within three working days to the "NDA-Field Alert Report" coordinator in the firm's jurisdictional FDA District Office, who also be available to answer any questions a firm may have regarding the reports.

A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial that will form the primary basis of an efficacy claim in an NDA. Which of the following is TRUE? A. The sponsor should submit the SPA request within 30 days following the start of the trial to expedite FDA feedback B. An SPA provides an opportunity to focus on general drug development issues C. The SPA request will be handled as a request for a Type B meeting D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the same protocol

D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the same protocol The agency can communicate with the sponsor regarding the protocol before issuing a Special Protocol Assessment letter. In such cases, the sponsor can choose to submit a revised protocol. If a sponsor submits a revised protocol, for any reason, while the agency is reviewing an earlier version of the same protocol, FDA ordinarily will not respond to the questions posed about the earlier version of the protocol and will consider the original request withdrawn. The agency will consider a request for a Special Protocol Assessment of a revised protocol to be a new request and will act on the revised protocol within 45 days.

A company intends to add an indication for use to a 510(k) device that is currently being marketed, but has not yet been distributed. Which type of submission is most appropriate? A. A PMA B. An Investigational Device Exemption C. A Special 510(k) D. A traditional or abbreviated 510(k)

D. A traditional or abbreviated 510(k) A Traditional 510(k) is required for changes involving indications for use.

A company intends to add an indication for use to a 510(k) device that is currently being marketed but has not yest been distributed. Which type of submission is appropriate? A. A PMA B. An Investigation Device Exemption C. A Special 510(k) D. A traditional or abbreviated 510(k)

D. A traditional or abbreviated 510(k) A Traditional 510(k) is required for changes involving indications for use. Regulatory Reference: FDA Guidance on When to Submit a New 510(k) for a Device Change.

Which statement is true about over the counter (OTC) drugs? A. They are regulated by the Division of Over the Counter Drugs B. A prescription to over the counter switch is automatic after 3 years of sufficient marketing experience if no serious or life threatening events were reported to FDA C. For most OTC drugs, an initial NDA was submitted for their use (they were not sold as prescription) D. Additional clinical studies may be required to justify OTC use and safety of use without the intervention of a physician

D. Additional clinical studies may be required to justify OTC use and safety of use without the intervention of a physician

A company begins to market its new device, a pacemaker (Class III) the same day that its regulatory professional mails the Premaket Approval Application (PMA) to FDA. The pacemaker is considered: A. Legally marketed B. Misbranded C. Investigational D. Adulterated

D. Adulterated Class III medical device is adulterated if it doesn't have an approved PMA and is not otherwise exempt. A legally marketed device in the US has been cleared, approved or exempted from review by the Food and Drug Administration. Regulatory Reference: 21 CFR Part 814.

The difference between advertising and professional labeling is that: A. Advertising can be directed to only consumers and professional labeling can be directed to only professionals B. Advertising must be accompanied by a PI while professional labeling must be accompanied by a brief summary C. Advertising can be directed to either consumers or professionals while professional labeling can be directed to only consumers D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI

D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI

The difference between advertising and professional labeling is that: A. Advertising can be directed to only consumers and professional labeling can be directed to only professionals. B. Advertising must be accompanied by a PI while professional labeling must be accompanied by a brief summary. C. Advertising can be directed to either consumers or professionals while professional labeling can be directed to only consumers. D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI.

D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI.

The difference between advertising and professional labeling is: A. Advertising can be directed only to consumers and professional labeling can be directed only to professionals. B. Advertising must be accompanied by a PI while professional labeling must be accompanied by a brief summary. C. Advertising can be directed to either consumers or professionals while professional labeling can be directed only to consumers. D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI.

D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI.

The difference between advertising and professional labeling is that: A. Advertising can be directed to only consumers and professional labeling can be directed to only professionals. B. Advertising must be accompanied by a PI while professional labeling must be accompanied by a brief summary. C. Advertising can be directed to either consumers or professionals while professional labeling can be directed to only consumers. D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI.

D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a PI. This statement is true.

The difference between advertising and professional labeling for prescription drugs is: A. Advertising can be directed only to consumers and professional labeling can be directed only to professionals. B. Advertising must be accompanied by a package insert while professional labeling must be accompanied by a brief summary. C. Advertising can be directed to either consumers or professionals while professional labeling can be directed only to consumers. D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a package insert.

D. Advertising must be accompanied by a brief summary and professional labeling must be accompanied by a package insert. Per 21 CFR 202.1, prescription drug advertisements include true statement of information in brief summary relating to side effects, contraindications and effectiveness.

Which of the following is NOT true of an Advisory Committee? A. Advisory Committee meetings can include an oral presentation from a patient advocacy group. B. Advisory Committee members are selected without regard to race, ethnicity, sex, age or religion. C. Advisory Committees provide advice to FDA on safety and effectiveness of drugs. D. Advisory Committees recommend whether a drug should be approved and do not provide advice on product labeling or clinical trial design.

D. Advisory Committees recommend whether a drug should be approved and do not provide advice on product labeling or clinical trial design. The Advisory Committee can review and make recommendations on any matter before the FDA; see 21 CFR 14.1(a)(1). The Advisory Committee advises for human prescription drugs "on the safety and effectiveness, including the labeling and advertising." See 21 CFR 14.160(a).

Which of the following is NOT true of an Advisory Committee? A. Advisory Committee meetings can include an oral presentation from a patient advocacy group. B. Advisory Committee members are selected without regard to race, ethnicity, sex, age or religion. C. Advisory Committees provide advice to FDA on safety and effectiveness of drugs. D. Advisory Committees recommend whether a drug should be approved and do not provide advice on product labeling or clinical trial design.

D. Advisory Committees recommend whether a drug should be approved and do not provide advice on product labeling or clinical trial design. The Advisory Committee can review and make recommendations on any matter before the FDA. 21 CFR 14.1(a)(1). The Advisory Committee advises for human prescription drugs "on the safety and effectiveness, including the labeling and advertising." 21 CFR 14.160(a).

510(k)s are not required when: A. you make an unfinished device B. you are repackaging/relabeling C. you are an import agent D. All of the above

D. All of the above

Drugs approved through which one of the following applications will be included in the Orange Book as the "listed drug": A. 505(b)(1) NDA B. 505(b)(2) Application C. ANDA D. All of the above

D. All of the above

What is the mission of the FDA? A. Promote public health B. Protect public health C. Pursue international harmonization D. All of the above

D. All of the above

Which of the following can be the ground of disapproval of IDE : A. The application omits required information B. The application has deficiencies in clinical plan and manufacturing methods C. The application depicts inadequate monitoring and review procedures D. All of the above

D. All of the above

The regulatory affairs practitioner's company manufacturers a product which requires a power source. All of the following US associations could assist in obtaining the information necessary for compliance with European standards EXCEPT the: A. Advanced Medical Technology Association. B. National Electrical Manufacturers Association. C. American National Standards Institute. D. American Society for Testing and Materials.

D. American Society for Testing and Materials. A. This represents domestic manufacturers of medical devices and diagnostic products; gathers and disseminates information concerning US and international developments. B. This represents manufacturers concerned with quality and reliability of electrical products. C. This serves as a clearinghouse for safety, engineering, electrical and industrial standards, representing the US internationally. D. This establishes voluntary standard testing methods for materials, products, systems and services; electrical sources not involved.

A manufacturer changes the size and shape of a container for a non-sterile solid dosage form drug that is already approved by FDA. What is the most appropriate vehicle for this action? A. Postapproval Supplement Changes Being Effected - Immediate 0 Days B. Postapproval Supplement Changes Being Effected in 30 days(CBE30) C. Prior Approval Supplement (PAS) D. Annual Report

D. Annual Report

FDA has granted approval to market a product and has required a postmarketing commitment from the sponsor. The sponsor is required to gather additional information about the product's safety and use. Under which of the following situations could FDA require the postmarketing study? A. Approval granted in accordance with accelerated approval provisions B. Optimal usage of the drug product (such as a new indication) is to be further defined C. The study is deferred pediatric study under PREA D. Approval granted accordance with accelerated approval provisions, or the study is a deferred pediatric study under PREA

D. Approval granted accordance with accelerated approval provisions, or the study is a deferred pediatric study under PREA

An IVD submission could be submitted as a(n): A. NDA B. BLA C. 510(k) D. BLA or 510(k)

D. BLA or 510(k) IVDs can be submitted as a 510(k) under the Food, Drug, and Cosmetic Act or a BLA under the Public Health Service Act. Regulatory Reference: Public Health Service Act, Food, Drug, and Cosmetic Act.

While examining complaint files, a quality assurance professional notices that there are several complaints of microbial contamination of one product lot. To determine the possible source of the problem, what records should be examined first? A. Sterilization and water system validations B. Environmental monitoring C. Raw material/supplier records D. Batch or device history record

D. Batch or device history record A. These are secondary records. B. See explanation A. C. See explanation A. D. Batch records or device history records should be examined first to look for production deviations during the manufacture of that lot.

While examining complaint files, a quality assurance practitioner notices that there are several complaints of microbial contamination of one product lot. To determine the possible source of the problem, which records should be examined first? A. Sterilization and water system validations B. Environmental monitoring C. Raw material/supplier records D. Batch or product history record

D. Batch or product history record A. These are secondary records. B. These are secondary records. C. These are secondary records. D. Batch records or device history records should be examined first to look for production deviations during the manufacture of that lot.

Which type of protocol is NOT eligible for a Special Protocol Assessment under the PDUFA? A. Animal carcinogenicity study protocol B. Phase 3 clinical study protocol, which its data is the primary basis for an efficacy claim C. Final product stability study protocol D. Bioequivalence study protocol

D. Bioequivalence study protocol As provided in FDA's Guidance for Industry: Special Protocol Assessment (May 2002), BE studies are not part of the PDUFA goals for special protocol assessment.

Which type of protocol is NOT eligible for a Special Protocol Assessment under the PDUFA? A. Animal carcinogenicity study protocol. B. Phase 3 clinical study protocol, which its data is the primary basis for an efficacy claim. C. Final product stability study protocol. D. Bioequivalence study protocol.

D. Bioequivalence study protocol. As provided in FDA's Guidance for Industry Special Protocol Assessment (May 2002), BE studies are not part of the PDUFA goals for special protocol assessment.

A company is submitting a PMA for a permanent implant. The company has performed biocompatibility testing based on ISO requirements and believes the package is complete. Which of the following testing does the company absolutely need to demonstrate long-term safety of its device? A. Intracutaneous irritation B. Genotoxicity C. Acute toxicity D. Carcinogenicity

D. Carcinogenicity Carcinogenicity is required to demonstrate long-term safety of an implant. All other testing is required for acute safety.

A 510(k) submission for any Class III device MUST include: A. Clinical results summary. B. Hazards analysis evaluation. C. Stability evaluation. D. Certification and summary.

D. Certification and summary.

A 510(k) submission for any Class III device MUST include: A. Clinical results summary. B. Risk analysis. C. Stability evaluation. D. Certification and summary.

D. Certification and summary. As required by 21 CFR 807.87(j), a 510(k) for a Class III device must include a Class III certification and summary as defined in 21 CFR 807.3(p and q) and 807.94.

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of: A. Class I and II devices B. Class I devices only C. Class II devices only D. Class II and III device

D. Class II and III device Class I devices are the least hazardous and are not the primary focus of FDA inspections. Third party inspections allow FDA to focus on higher-risk inspections.

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of: A. Class I and II devices. B. Class I devices only. C. Class II devices only. D. Class II and III devices.

D. Class II and III devices.

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of: A. Class I and II devices. B. Class I devices only. C. Class II devices only. D. Class II and III devices.

D. Class II and III devices. Class I devices are the least hazardous and are not the primary focus of FDA inspections. Third party inspections allow FDA to focus on higher-risk inspections.

Your company submitted a supplement that is subject to the Pediatric Research Equity Act (PREA). As you develop your clinical study plan, the best study design might include the following considerations, EXCEPT: A. Assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations B. Support dosing for each pediatric subpopulation for which the product has been assessed to be safe and effective C. Support drug route of administration for each pediatric subpopulation for which the product has been assessed to be safe and effective D. Compare the safety and effectiveness of the product for the claimed indications in pediatric and adult patients

D. Compare the safety and effectiveness of the product for the claimed indications in pediatric and adult patients Comparative clinical studies between adults and pediatric subjects are not a requirement for pediatric labeling and approval.

A final report for a nonclinical laboratory study must include all of the following EXCEPT: A. Name and address of the facility performing the study B. Statistical methods employed for analyzing the data C. Description of all circumstances that may have affected the quality or integrity of the data D. Complete listing of all specimens that remain in storage

D. Complete listing of all specimens that remain in storage The final report must include the locations where all specimens are stored; see 21CFR58.185(a)(13). A complete listing is not required.

A final report for a nonclinical laboratory study must include all of the following EXCEPT: A. Name and address of the facility performing the study B. Statistical methodsemployed for analyzing the data C. Description of all circumstances that may have affected the quality or integrity of the data D. Complete listing of all specimens that remain in storage

D. Complete listing of all specimens that remain in storage The final report must include the locations where all specimens are stored; see 21CFR58.185(a)(13). A complete listing is not required.

Which of the following is exempt from GMP/QS regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers

D. Component manufacturers Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).

Which of the following is exempt from GMP/QSR regulations? A. Remanufacturers B. Custom device manufacturers C. Repackagers D. Component manufacturers

D. Component manufacturers Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).

Which of the following is exempt from GMP/QS regulations? A. Remanufacturers. B. Custom device manufacturers. C. Repackagers. D. Component manufacturers.

D. Component manufacturers. Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).

FDA will do a for-cause inspection of an investigator if the investigator: A. Conducts a number of pivotal NDA studies. B. Is only participating in a small number of studies. C. Appears to have an excessive number of study projects. D. Consistently reports results different from other investigators.

D. Consistently reports results different from other investigators.

FDA will do a for-cause inspection of an investigator if the investigator: A. Conducts a number of pivotal NDA studies. B. Is only participating in a small number of studies. C. Appears to have an excessive number of study projects. D. Consistently reports results different from other investigators.

D. Consistently reports results different from other investigators. An inspection will be conducted if an investigator's results are inconsistent with those of other investigators and fraud is suspected.

Per 21 CFR 820, a clinical study to establish safety and effectiveness of a device is considered: A. Design verification B. Pivotal C. First in man D. Design validation

D. Design validation The clinical study is objective evidence the device specifications conform with the user needs and intended use.

There is a fire in a company warehouse that contains drug and device products. Which of the following should the regulatory professional do first? A. Inform FDA immediately. B. Refer press questions to the public relations office. C. Authorize export of products that have passed inspection for visual damage. D. Dispatch an auditor to the site.

D. Dispatch an auditor to the site. A. Since the products have not left the company warehouse, there is no need to notify FDA. B. This is appropriate, but should not be the first action. C. Although export may be an option at some point, visual inspection may not ensure product quality. D. An auditor should be dispatched to make an immediate assessment of involvement of the products.

Senior management at your company asked you to develop a justification for Fast Track status for an investigational new cancer drug. Which of the following would NOT be an appropriate justification for FDA granting Fast Track status for this investigational new drug? A. Preliminary evidence indicates the new drug may decrease clinically significant toxicity of available treatment B. Cancer is considered by FDA to be a serious disease C. Preliminary evidence indicates the new drug has potential for superior effectiveness compared to available treatment D. Documentation can be provided that the cancer drug meets safety and effectiveness standards required for Fast Track status

D. Documentation can be provided that the cancer drug meets safety and effectiveness standards required for Fast Track status Fast Track status does not comprise or alter the standards for the safety and effectiveness of the drugs that become available through this process.

Which of the following type of protocols would NOT be eligible for a Special Protocol Assessment review process with FDA? A. Animal carcinogenicity protocols B. Stability protocol C. Protocol for Phase 3 trials related to efficacy claim D. Dose ranging protocol

D. Dose ranging protocol Per guidance issued, dose ranging protocols are not to be submitted as an SPA.

Which of the following type of protocols would NOT be eligible for a Special Protocol Assessment review process with FDA? A. Animal carcinogenicity protocols B. Stability protocol C.Protocol for Phase 3 trials related to efficacy claim D. Dose ranging protocol

D. Dose ranging protocol Per guidance issued, dose ranging protocols are not to be submitted as an SPA.

Which of the following federal laws includes information about ANDA submissions? A. Antibiotic Amendments of 1945 B. Durham-Humphrey Amendment of 1951 C. Drug Amendments of 1962 D. Drug Price Competition and Patent Term Restoration Act

D. Drug Price Competition and Patent Term Restoration Act A. This amendment required certification of penicillin drugs. B. This amendment coded pharmaceutical products into OTC and prescription medications. C. These amendments required that a manufacturer demonstrate proof of effectiveness in addition to safety, before marketing any new drug. D. This Act permitted manufacturers to use abbreviated NDAs to gain approval for generic versions of approved drugs whose patents had expired.

Which of the following federal laws includes information about ANDA submissions? A. Antibiotic Amendments of 1945 B. Durham-Humphrey Amendment of 1951 C. Drug Amendments of 1962 D. Drug Price Competition and Patent Term Restoration Act of 1984

D. Drug Price Competition and Patent Term Restoration Act of 1984 This Act permitted manufacturers to use abbreviated NDAs to gain approval for generic versions of approved drugs whose patents had expired.

Which of the following federal laws includes information about ANDA submissions? A. Antibiotic Amendments of 1945. B. Durham-Humphrey Amendment of 1951. C. Drug Amendments of 1962. D. Drug Price Competition and Patent Term Restoration Act of 1984.

D. Drug Price Competition and Patent Term Restoration Act of 1984. This Act permitted manufacturers to use abbreviated NDAs to gain approval for generic versions of approved drugs whose patents had expired.

FDA may perform a pre-approval inspection of an applicant's manufacturing facility before approving an application. The filing of which of the following submissions does not automatically activate the consideration of a pre-approval inspection? A. New Drug Application B. Abbreviated New Drug Application C. Pre-Market Approval Application D. Drug/Device Master File

D. Drug/Device Master File A. FDA may conduct a pre approval inspection. B. See explanation A. C. See explanation A. D. FDA regulations do not require pre-approval inspections of Drug/Device Master Files

FDA may perform a pre-approval inspection of an applicant's manufacturing facility before approving an application. The filing of which of the following submissions does not automatically activate the consideration of a pre-approval inspection? A. New Drug Application B. Abbreviated New Drug Application C. Pre-Market Approval Application D. Drug/Device Master File

D. Drug/Device Master File FDA regulations do not require pre-approval inspections of Drug/Device Master Files.

FDA may perform a pre-approval inspection of an applicant's manufacturing facility before approving an application. The filing of which of the following submissions does NOT automatically activate the consideration of a pre-approval inspection? A. New Drug Application. B. Abbreviated New Drug Application. C. Pre-Market Approval Application. D. Drug/Device Master File.

D. Drug/Device Master File. FDA regulations do not require pre-approval inspections of Drug/Device Master Files.

MDUFMA authorized 3rd party establishment inspections. All of the following are true about these inspections EXCEPT: A. You (sponsor) need to market at least one device in the United States B. Participation is voluntary C. In order to be eligible, an establishment's most recent inspection must be NAI or VAL D. Establishments are not required to obtain clearance of a 3rd party in advance

D. Establishments are not required to obtain clearance of a 3rd party in advance

A manufacturer is closing its current facility for manufacturing an approved drug product. The manufacturer has two other facilities, and has asked regulatory to examine the two locations and develop an appropriate regulatory strategy. Facility A: A large facility being built near the existing facility will have state-of-the-art electronics to monitor the manufacturing process, all new isolated manufacturing areas and all new equipment. The new facility will open one month before the current facility is scheduled to close. This manufacturing process will be the first process moved to this new building. Facility B: A smaller facility 100 miles away from the existing facility has been manufacturing several approved drug products for the same therapeutic purpose for the past 15 years Which is the most accurate analysis/recommendation? A. The transfer of the manufacturing process to Facility A is considered a minor change and will only require a notation of the transfer of the manufacturing process from the current location in the drug product Annual Report. There would be no impact on the manufacturing process or the availability of the drug product. B. Facility A will have a significant positive impact on drug product quality due to the electronic monitoring system and new equipment. The transfer of the manufacturing process to Facility A would be considered a moderate change and could be filed in a CBE 30. C. The transfer of the process to the older Facility B would be considered a major change and would require prior approval from FDA of the change before the drug product could be placed onto the market. D. Facility B has been manufacturing approved drug products for the same therapeutic purpose for the past 15 years and has been inspected by FDA. The move of the manufacturing process to Facility B would be a moderate change and could be filed in a CBE 30.

D. Facility B has been manufacturing approved drug products for the same therapeutic purpose for the past 15 years and has been inspected by FDA. The move of the manufacturing process to Facility B would be a moderate change and could be filed in a CBE 30. The transfer of a drug product manufacturing process to a new facility requires notification of FDA of the change to the process. In reviewing Facilities A and B, the regulatory professional would recognize that Facility A, although new and state-of-the-art, has not been inspected by FDA and would result in a major change to the approved NDA. This major change would require a prior approval before drug product manufactured in this location could be placed onto the market. Reporting of this manufacturing change in an Annual Report would be incorrect. The transfer of the manufacturing process to Facility B, however, would be a moderate change as FDA has inspected it for the other drug products it currently manufactures. This is considered a moderate change and would result in a Changes Being Effected (CBE) 30 notification to FDA prior to placing the drug product manufactured on the market.

The regulatory affairs practitioner receives a telephone call from a distraught mother claiming that her child is is due to medical waste products which have been disposed of improperly. She identified the practitioner's company's name on the packaging. Which of the following should be done first? A. Contact medical affairs. B. Contact plant waste disposal. C. Contact public relations. D. Follow company policy.

D. Follow company policy. This policy would identify the course of action and potential liabilities, and would coordinate involvement of the other departments.

Which of the following does not discuss the protection of human subjects? A. Nuremberg Code B. Declaration of Helsinki C. Drug Amendment of 1962 D. Food Drug and Cosmetic Act of 1938

D. Food Drug and Cosmetic Act of 1938 A. Nuremberg Code of Ethics in Medical Research required a subject's informed consent. B. Declaration of Helsinki, adopted in 1964, by the World Health Organization, also discussed the rights of human subjects. C. The FDA regulations did not address informed consent until the Drug Amendment of 1962. D. Correct.

Which of the following manufacturers must register their manufacturing facility with FDA? A. Component manufacturers who sell only to the device manufacturer using their components B. Domestic (US) contract manufacturers who follow another person's specifications and do not commercially distribute the devices to the market C. Domestic manufacturer of device being investigated under an IDE D. Foreign manufacturers shipping devices into the US for sale in the US.

D. Foreign manufacturers shipping devices into the US for sale in the US. All foreign manufacturers making devices distributed in the US must register with FDA.

Unless exempt, all donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) must be tested for RCDADs (Relevant Communicable Disease Agents and Disease), which include: A. HIV (Type 1 and Type 2), Hepatitis B, B. HIV (Type 1 and Type 2) and Treponema pallidum C. HIV (Type 1 and Type 2) and Hepatitis C D. HIV (Type 1 and Type 2), Hepatitis B, Hepatitis C and Treponema pallidum

D. HIV (Type 1 and Type 2), Hepatitis B, Hepatitis C and Treponema pallidum Per 21 CFR 1271.85, a specimen from the donor of cells or tissue, whether viable or nonviable, must be tested for evidence of infection due to relevant communicable disease agents including: HIV (Type 1 and Type 2), Hepatitis B, Hepatitis C and Treponema pallidum. Sec. 1271.85 What donor testing is required for different types of cells and tissues? —(a) All donors. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under 1271.90, you must test a specimen from the donor of cells or tissue, whether viable or nonviable, for evidence of infection due to relevant communicable disease agents, including: (1) Human immunodeficiency virus, type 1; (2) Human immunodeficiency virus, type 2; (3) Hepatitis B virus; (4) Hepatitis C virus; and (5)Treponema pallidum —(b) Donors of viable, leukocyte-rich cells or tissue. In addition to the relevant communicable disease agents for which testing is required under paragraph (a) of this section, and except as provided under 1271.90, (1) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue to adequately and appropriately reduce the risk of transmission of relevant cell-associated communicable diseases, including: (i) Human T-lymphotropic virus, type I; and (ii) Human T-lymphotropic virus, type II. (2) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue for evidence of infection due to cytomegalovirus (CMV), to adequately and appropriately reduce the risk of transmission. You must establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for CMV. —(c) Donors of reproductive cells or tissue. In addition to the communicable disease agents for which testing is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under 1271.90, you must test a specimen from the donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract. Such testing must include testing for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section. However, if the reproductive cells or tissues are recovered by a method that ensures freedom from contamination of the cells or tissue by infectious disease organisms that may be present in the genitourinary tract, then testing for the communicable disease agents listed in paragraphs (c)(1) and (c)(2) of this section is not required. Communicable disease agents of the genitourinary tract for which you must test include: (1) Chlamydia trachomatis; and (2) Neisseria gonorrhea.

Which of the following groups must be responsible for reviewing clinical investigations? A. hospital review board B. state medical society C. AMA Board of Review D. IRB

D. IRB Only the IRB has the authority to approve clinical investigations. 21 CFR 56

FDA defines a label as that which is affixed to the: A. Carton. B. Shrink wrapper. C. Shipping package. D. Immediate container.

D. Immediate container. The term "label" has a narrow meaning limited to the display of written, printed or graphic matter upon the immediate container of an article. 21 CFR 201 (Subpart A).

A new drug product is being considered by your company. It has been on the market for more than 30 years in a foreign country, but has never been approved in the US. In order to sell this product in the US, you may do the following immediately EXCEPT: A. Determine monograph or NDA status of the product B. Initiate clinical studies in the foreign country to support the claims since the clinical data is old and would not meet current requirements C. Determine whether this is a New Chemical Entity D. Import the product and use new labeling

D. Import the product and use new labeling The importation of a drug product to be distributed in the US must meet US regulations, regardless of its approved status in another country.

For human biological sample, the donor eligibility system includes all of the following EXCEPT: A. Confirms donor identity and correlates medical records, test results and components to donor record B. Procedure to reject ineligible donor C. Notify donors of deferred status D. Interviewing the donors spouse or partner to establish a thorough donor profile

D. Interviewing the donors spouse or partner to establish a thorough donor profile

Which of the following is not a component of an ANDA submission A. Form FDA 356h B.Bioavailability/Bioequivalence C. Labeling D. Investigator's Brochure

D. Investigator's Brochure

While reviewing the data for an upcoming New Drug Application (NDA) submission, the in-house monitor found the investigator's Curriculum Vitae (CV) has not been updated since it was submitted with the Investigational New Drug (IND) application. According to FDA guidance on Form 1572, how often should the investigator's CV updated? A. Annually B. Every two years C. Every three years D. It does not need to be updated

D. It does not need to be updated FDA regulations do not require a CV or other statement of qualifications to be updated during a clinical study.

While reviewing the data for an upcoming, New Drug Application (NDA) submission, the in-house monitor found that the investigator's Curriculum Vitae (CV) had not been updated throughout an Investigational New Drug (IND) Study. According to FDA guidance on Form FDA 1572, how often should the investigator's CV be updated? A. Annually B. Every 2 years C. Every 3 years D. It does not need to be updated

D. It does not need to be updated (if qualified at the onset of the study any additional qualification doesn't need to be updated)

During an audit of a manufacturing site, the FDA inspector learned that complaints from the field were not being adequately documented. At the closing meeting, the FDA inspector presented: A. Establishment Inspection Report (EIR) B. Establishment Registration Report (ERR) C. Summary of Inspectional Findings (FD-481) D. List of Observations (FD-483)

D. List of Observations (FD-483) A. Summary document often written by FDA inspector several weeks after he/she leaves the firm. B. No such document exists. C. No such document exists. D. Inspector shares this form with the firm before leaving the site.

During an audit of a manufacturing site, the FDA inspector learns that complaints from the field are not being adequately documented. At the closing meeting, the FDA inspector presents which of the following documents? A. Establishment Inspection Report (EIR) B. Establishment Registration Report (ERR) C. Summary of Inspectional Findings (FD-481) D. List of Observations (FD-483)

D. List of Observations (FD-483) Inspector shares this form with the firm before leaving the site.

During an audit of a manufacturing site, the FDA inspector learns that complaints from the field are not being adequately documented. At the closing meeting, the FDA inspector presents: A. Establishment Inspection Report (EIR). B. Establishment Registration Report (ERR). C. Summary of Inspectional Findings (FD-481). D. List of Observations (FD-483).

D. List of Observations (FD-483).

Which of the following is NOT TRUE for a Memorandum of Understanding (MOU)? A. MOUs clarify the regulatory responsibilities between the FDA and other federal agencies. B. MOUs delineate roles and authority of the FDA and state governments. C. New MOUs are announced in the Federal Register. D. MOUs are binding agreements that describe the inspection procedures used by agencies collaborating with the FDA.

D. MOUs are binding agreements that describe the inspection procedures used by agencies collaborating with the FDA. MOUs are non-binding agreements.

Which of the following is NOT TRUE for a Memorandum of Understanding (MOU)? A. MOUs clarify the regulatory responsibilities between the FDA and other federal agencies B. MOUs delineate roles and authority of the FDA and state governments C. New MOUs are announced in the Federal Register D. MOUs describe the inspection procedures used by agencies working in collaboration with the FDA

D. MOUs describe the inspection procedures used by agencies working in collaboration with the FDA

A 505(b)(2) NDA is NOT an appropriate regulatory submission for the approval to market a: A. New Chemical Entity when FDA relies for approval on data not developed by the applicant B. Different route of administration for an approved product C. Combination of two active ingredients that have been approved individually D. New Chemical Entity when the sponsor has a right of reference to all applicable published studies

D. New Chemical Entity when the sponsor has a right of reference to all applicable published studies A 505(b)2 NDA is an application where approval of the new drug relies on data at least in part that is not developed by the applicant. 505(b)(2) Application means an application submitted under section 505(b)(1) of the act for a drug for which the investigations described in section 505(b)(1)(A) of the act and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.

A clinical investigator will conduct Phase 1 pharmacokinetic studies of your company's drug product. This same investigator also receives a $30,000 retainer to be on the speaker's bureau for another of your company's products. What information related to this investigator must be included with your IND submission? A. Form 3454, certifying lack of financial interests and arrangements. B. Form 3455, disclosing significant payments from the IND sponsor. C. Form 3455, disclosing proprietary interest in the tested product. D. No additional forms are required.

D. No additional forms are required. Phase 1 pharmacokinetic studies are not covered studies, and therefore do not need financial certification or disclosure.

A company is planning to develop a sunscreen with an ingredient cosistent with its published monograph for marketing within the US. What type of filing does the company have to submit? A. No action is required by the sponsor as it is a cosmetic B. ANDA C. 505(b)(1) D. No premarket approval is required

D. No premarket approval is required The active ingredients allowed for use in sunscreens are published in the final monograph 21 CFR 352. A product that includes a codified sunscreen ingredient does not require premarket approval by FDA provided the full conditions of the monograph are met.

Which of the following devices are not subject to requirements for Design Controls? A. Class I devices. B. Class II devices. C. Class III devices. D. None of the above.

D. None of the above.

You have modified your 510(k) cleared device with a special 510(k). In which of the following cases would you need to create a new listing for the device? A. You have added new sizes and shapes in the product portfolio. B. You have changed the material composition of the device. C. You have changed the package of the device. D. None of the above.

D. None of the above. According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for each device or device class listed with the FDA. Devices having variations in physical characteristics such as size, package, shape, color or composition should be considered to be one device: Provided, The variation does not change the function or intended use of the device.

You have modified your 510(k) cleared device with a special 510(k). In which ofthe following cases would you need to create a new listing for the device? A. You have added new sizes and shapes in the product portfolio. B. You have changed the material composition of the device. C. You have changed the package of the device. D. None of the above.

D. None of the above. According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for each device or device class listed with the FDA. Devices having variations in physical characteristics such as size, package, shape, color or composition should be considered to be one device: Provided, The variation does not change the function or intended use of the device.

A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specification won't change B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location C. The change does not have to be reported because it is an OTC drug D. Not enough information

D. Not enough information

A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specification won't change. B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location. C. The change does not have to be reported because it is an OTC drug. D. Not enough information.

D. Not enough information.

A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA? The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change. B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location. C. The change does not have to be reported because it is an OTC drug. D. Not enough information.

D. Not enough information. It is unclear from this question if the OTC drug product is an OTC monograph product for which there would be no FDA administrative file to report the change to, or if this is an NDA-OTC drug product (versus an NDA-Rx drug product). For an NDA-OTC drug product, the company would have an approved NDA file where they could send a supplement for review.

A subject in a drug clinical trial subject is involved in an automobile accident. As a result, an exploratory laparotomy is performed, that identifies a ruptured spleen. A splenectomy is performed, resulting in patient hospitalization. What, if any, reporting is required? A. The splenectomy should be reported as an adverse event. B. The splenectomy and automobile accident should be reported as an adverse event. C. The hospitalization should be reported. D. Nothing is required and the subject can continue in the study when recovered.

D. Nothing is required and the subject can continue in the study when recovered The splenectomy is related to the automobile accident, not the product being studied. Therefore, no report is required.

A subject in a drug clinical trial subject is involved in an automobile accident. As a result, an exploratory laparotomy is performed, that identifies a ruptured spleen. A splenectomy is performed, resulting in patient hospitalization. What, if any, reporting is required? A. The splenectomy should be reported as an adverse event. B. The splenectomy and automobile accident should be reported as an adverse event. C. The hospitalization should be reported. D. Nothing is required and the subject can continue in the study when recovered.

D. Nothing is required and the subject can continue in the study when recovered. The splenectomy is related to the automobile accident, not the product being studied. Therefore, no report is required.

An FDA investigator cannot begin an inspection of domestic facilities until which of the following has occurred? A. Manufacturing personnel are alerted B. Management has been notified C. Form FD-483 has been presented D. Notice of Inspection has been presented

D. Notice of Inspection has been presented D. Notice of Inspection must be issued 704(a)(1) FD&C Act Notice of Inspection 482.

An FDA investigator cannot begin an inspection of domestic facilities until which of the following has occurred? A. manufacturing personnel are alerted B. management has been notified C. Form FD-483 has been presented D. Notice of lnspection has been presented

D. Notice of lnspection has been presented Notice of inspection must be issued 704(a)(l) FD&C Act Notice of inspection 482.

Which one of the following certifications are submitted if and ANDA applicant wants to challenge an Orange Book-listed patent by claiming that the patent is "invalid or will not be infringed by the manufacture, use....." A. Paragraph I B. Paragraph II C. Paragraph III D. Paragraph IV

D. Paragraph IV

Under the Medical Device Quality System Regulation, device design requirements MUST meet the needs of the: A. Manufacturer B. Patient C. User D. Patient and user

D. Patient and user QSR requires design input as defined in 21 CFR 820. 30 (c) meet the needs of both the patient and user.

Which of the following is NOT a requirement for a sponsor to advertise that a prescription drug is safer or more effective than another prescription drug? A. The representation must have been approved as part of the labeling in a new drug application or biologic license B. The representation is supported by substantial evidence derived from adequate and well-controlled studies as defined by applicable regulation C. The requirement for adequate and well-controlled studies is waived by regulation D. Peer-reviewed scientific literature in support of the claim must be submitted in a preapproval supplement

D. Peer-reviewed scientific literature in support of the claim must be submitted in a preapproval supplement Peer-reviewed scientific literature in support of the claim is not required to be submitted in a preapproval supplement but should be supplied to the Food and Drug Administration, if requested. Sec. 202.1 Prescription-drug advertisements. (ii) In the case of an advertisement for a prescription drug other than a drug the labeling of which causes it to be an unapproved "new drug" and other than drugs covered by paragraph (e)(4)(i) of this section, an advertisement may recommend and suggest the drug only for those uses contained in the labeling thereof: (c) For which there exists substantial clinical experience (as used in this section this means substantial clinical experience adequately documented in medical literature or by other data (to be supplied to the Food and Drug Administration, if requested)), on the basis of which it can fairly and responsibly be concluded by qualified experts that the drug is safe and effective for such uses.

For nonclinical studies lasting more than six months, quality assurance audits are conducted at which of the following intervals? A. One month B. Quarterly C. At completion D. Periodically

D. Periodically A. Audits should be conducted at intervals appropriate to assure the integrity of the study. B. See explanation A. C. See explanation A. D. Periodic auditing by the quality assurance unit is required as appropriate for the study. 21 CFR 58.35(b)(3).

At what interval are quality assurance audits conducted for nonclinical studies lasting more than six months? A. Once per month B. Quarterly C. At completion D. Periodically

D. Periodically Periodic inspections by the quality assurance unit are required as appropriate for the study; see 21 CFR 58.35(b)(3).

At what interval are quality assurance audits conducted for nonclinical studies lasting more than six months? A. One month. B. Quarterly. C. At completion. D. Periodically.

D. Periodically.

At what interval are quality assurance audits conducted for nonclinical studies lasting more than six months? A. Once a month. B. Quarterly. C. At completion. D. Periodically.

D. Periodically. Periodic inspections by the quality assurance unit is required as appropriate for the study. 21 CFR 58.35(b)(3).

Commitment made by a sponsor in response to the FDA to conduct post NDA approval research involves which clinical research phase? A. Phase I B. Phase II C. Phase III D. Phase IV

D. Phase IV

Which of the following activities is regulated by FDA? A. Advertising of an OTC drug B. Advertising of a toothpaste that does not contain fluoride C. Refuse entry of an imported drug into US D. Placement of substances on a Class IV narcotic drug schedule

D. Placement of substances on a Class IV narcotic drug schedule A. FTC is in charge of advertising of OTC drugs. B. Non-fluoride toothpaste is not considered a drug; C.US Customs is the only US agency that has been granted authority to detain or refuse entry of imported products. D. Both DEA and FDA regulate Class IV narcotic drugs.

Which aspect of the medical products does the FDA NOT regulate? A. Clinical Investigations B. Commercialization C. Manufacturing D. Practice of Medicine

D. Practice of Medicine

For a medical device's product storage and handling system, each manufacturer shall establish and maintain all of the following EXCEPT: A. Separate rooms or cages for release and quarantine B. Procedures for the control of storage areas and stock used for shipping supplies C. Environmentally controlled areas for products with shelf life D. Procedure for rotation of stock

D. Procedure for rotation of stock

The following are required per 21 CFR Part 820 Quality System Regulation EXCEPT: A. Device History Record (DHR) B. Device Master Record (DMR) C. Design History File (DHF) D. Quality Manual (QM)

D. Quality Manual (QM) DHR is required per 21 CFR 820.184. DMR is required per 21 CFR 820.181. DHF is required per 21 CFR 820.30. Quality Manual is a requirement of ISO13485:2007. It is not required by QSR, although such a manual would be helpful in explaining the nature and extent of the QMS to an FDA investigator during an inspection.

The following are required per 21 CFR Part 820 Quality System Regulation (QSR) EXCEPT: A. Device History Record (DHR) B. Device Master Record (DMR) C. Design History File (DHF) D. Quality Manual (QM)

D. Quality Manual (QM) DHR is required per 21 CFR 820.184. DMR is required per 21 CFR 820.181. DHF is required per 21 CFR 820.30. Quality Manual is a requirement of ISO13485:2003. It is not required by QSR, although such a manual would be helpful in explaining the nature and extent of the QMS to an FDA investigator during an inspection. Regulatory Reference: 21 CFR Part 820 and ISO 13485.

A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not properly consented one-third of its subjects. What is the FIRST thing the company needs to do? A. Stop the entire study B. Inform FDA and ask for guidance C. Re-train the study staff, including the principle investigator at that site on GCP D. Re-consent all improperly consented subjects

D. Re-consent all improperly consented subjects The improperly consented subjects must be properly consented immediately, and all study staff responsible for the conduct of the study need to be re-trained immediately after that. The company would also need to notify FDA to ask for guidance. The last measure should be to terminate the noncompliant site.

A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not properly consented one-third of its subjects. What is the FIRST thing the company needs to do? A. Stop the entire study B. Inform FDA and ask for guidance C. Re-train the study staff, including the principle investigator at that site on GCP D. Re-consent all improperly consented subjects

D. Re-consent all improperly consented subjects The improperly consented subjects must be properly consented immediately, and all study staff responsible for the conduct of the study need to be re-trained immediately after that. The company would also need to notify FDA to ask for guidance. The last measure should be to terminate the noncompliant site.

Which of the following changes require FDA approval of NDA supplements before the change is made? A. Adding an additional test method B. Deleting a dye from the drug product C. Making changes that comply with USP D. Relaxing the limits for a drug products specification

D. Relaxing the limits for a drug products specification Prior FDA approval is required for a noncompendial relaxation of release specification limits; See 21 CFR 314.70.

Which of the following changes require FDA approval of NDA supplements before the change is made? A. Adding an additional test method B. Deleting a dye from the drug product C. Making changes that comply with USP D. Relaxing the limits for a drug substance specification

D. Relaxing the limits for a drug substance specification A. Additional testing above that which is already approved does not require prior FDA approval. B. Prior FDA approval is not required providing the dye affects only the color of the drug product. C. Conformance to a change made to an official compendium does not require prior FDA approval. D. Prior FDA approval is required for a noncompendial relaxation of release specification limits. 21 CFR 314.70.

Which of the following changes require FDA approval of NDA supplements before the change is made? A. Adding an additional test method. B. Deleting a dye from the drug product. C. Making changes that comply with USP. D. Relaxing the limits for a drug substance specification.

D. Relaxing the limits for a drug substance specification. Prior FDA approval is required for a noncompendial relaxation of release specification limits. 21 CFR 314.70.

Your company is developing a New Chemical Entity (NCE) drug to treat Glioblastoma multiforme, which is the deadliest and most common form of malignant brain tumor. The compound team has designed a pivotal study protocol with a clinically meaningful and well-established primary endpoint. To increase the likelihood FDA will agree with the study design, which of the following regulatory strategies has to occur prior to initiating the pivotal study? A. Request Fast Track designation B. Request priority review C. Request approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life Threatening Illness D. Request Special Protocol Assessment

D. Request Special Protocol Assessment A Special Protocol Assessment applies to a Phase 3 study and has to be requested prior to initiating the study, so answer 4 is correct. Fast Track designation can be requested at any time. Priority review is requested prior to filing an NDA, not prior to clinical studies. Answer 3 is not applicable to this case, as Subpart H applies to utilization of surrogate, not well-established endpoints.

Your company is developing a New Chemical Entity (NCE) drug to treat Glioblastoma multiforme, which is the deadliest and most common form of malignant brain tumor. The compound team has designed a pivotal study protocol with a clinically meaningful and well-established primary endpoint. To increase the likelihood FDA will agree with the study design, which of the following regulatory strategies has to occur prior to initiating the pivotal study? A. Request Fast Track designation B. Request priority review C. Request approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life Threatening Illness D. Request Special Protocol Assessment

D. Request Special Protocol Assessment A Special Protocol Assessment applies to a Phase 3 study and has to be requested prior to initiating the study, so answer D is correct. Fast Track designation can be requested at any time. Priority review is requested prior to filing an NDA, not prior to clinical studies. Answer C A company is developing a new device, and the device classification under which it would fall is not clear. As the regulatory professional, you would make the following submission: is not applicable to this case, as Subpart H applies to utilization of surrogate, not well-established endpoints.

The Quality System Regulation includes requirements for Design Controls. All of the following statements about Design Reviews are true EXCEPT: A. Manufacturers are required to maintain procedures to ensure that formal reviews occur at appropriate stages of a device's design and development. B. Participation at design reviews must include representatives of all functions concerned with the stage being reviewed. C. Participation shall include at least one individual who does not have direct responsibility for the stage being reviewed. D. Results of the design review shall be documented in the device history record.

D. Results of the design review shall be documented in the device history record. The results of the design review shall be documented in the device history file (DHF); see 21 CFR 820.30(e).

The Quality System Regulation includes requirements for Design Controls. All of the following statements about Design Reviews are true EXCEPT: A. Manufacturers are required to maintain procedures to ensure that formal reviews occur at appropriate stages of a device's design and development. B. Participation at design reviews must include representatives of all functions concerned with the stage being reviewed. C. Participation shall include at least one individual who does not have direct responsibility for the stage being reviewed. D. Results of the design review shall be documented in the device history record.

D. Results of the design review shall be documented in the device history record. The results of the design review shall be documented in the device history file (DHF); see 21 CFR 820.30(e).

When multiple facilities are involved in the design, assembly or processing of a Class III device, the PMA holder should do all of the following except: A. Ensure the Quality System in all facilities is in compliance with 21 CFR 820 regulations, as applicable B. Include in the PMA submission a complete description of the methods used in the manufacture, processing, packing, storage and installation of the device C. Provide written authorization to reference the Device Master File information from a contracted facility D. Submit Quality System information only for the facility involved in the design of the device

D. Submit Quality System information only for the facility involved in the design of the device

A company is developing an unapproved drug-device combination product in which the primary mode of action is the drug. What application type and to which center should the company submit their application for approval to market the drug? A. Submit a PMA to CDRH B. Submit an IND application to CDER C. Submit a Premarket Notification application to CDRH D. Submit a New Drug Application to CDER

D. Submit a New Drug Application to CDER

A company is developing an unapproved drug-device combination product in which the primary mode of action is the drug. What application type and to which center should the company submit their application for approval to market the drug? A. Submit a Premarket Application to CDRH B. Submit an Investigational New Drug Application to CDER C. Submit a Premarket Notification application to CDRH D. Submit a New Drug Application to CDER

D. Submit a New Drug Application to CDER The primary mode of action determines the center to which a company should submit its application. Because the primary mode of action in this case is a drug, a new drug application should be submitted to CDER.

A company has promising results from preclinical studies of a biologic agent in a mouse model that indicate the agent is effective against a lab-developed strain of pathogen considered to be a potential bioterrorism agent. Infection by the bioterrorism agent is known to cause irreversible morbidity or death. At this point, how should the company proceed? A. Submit an IND and commence clinical studies to demonstrate safety and effectiveness B. Submit an IND and design clinical safety and efficacy studies using a surrogate endpoint for approval of the product under 21 CFR 601 Subpart E C. Submit an IND and design clinical safety and efficacy studies using a surrogate endpoint for approval of the product under 21 CFR 314 Subpart E D. Submit an IND to start clinical safety trials in humans for approval of the product under 21 CFR 601 Subpart H.

D. Submit an IND to start clinical safety trials in humans for approval of the product under 21 CFR 601 Subpart H. Because the target of the drug (the biothreat) causes irreversible morbidity or death, clinical efficacy studies in humans are not ethical. This eliminates choices 1, 2 and 3. However, approval under the Animal Rule (21 CFR 601 Subpart H) requires clinical safety data (to be completed in healthy volunteers).

A company has promising results from preclinical studies of a biologic agent in a mouse model that indicate the agent is effective against a lab-developed strain of pathogen considered to be a potential bioterrorism agent. Infection by the bioterrorism agent is known to cause irreversible morbidity or death. At this point, how should the company proceed? A. Submit an IND and commence clinical studies to demonstrate safety and effectiveness B. Submit an IND and design clinical safety and efficacy studies using a surrogate endpoint for approval of the product under 21 CFR 601 Subpart E C. Submit an IND and design clinical safety and efficacy studies using a surrogate endpoint for approval of the product under 21 CFR 314 Subpart E D. Submit an IND to start clinical safety trials in humans for approval of the product under 21 CFR 601 Subpart H.

D. Submit an IND to start clinical safety trials in humans for approval of the product under 21 CFR 601 Subpart H. Because the target of the drug (the biothreat) causes irreversible morbidity or death, clinical efficacy studies in humans are not ethical. This eliminates choices A, B and C. However, approval under the Animal Rule (21 CFR 601 Subpart H) requires clinical safety data (to be completed in healthy volunteers).

A Special 510(k) must contain all of the following components EXCEPT: A. Proposed Labeling B. Design Controls Activity Summary C. 510(k) Summary or 510(k) Statement D. Summary of Safety and Effectiveness Data

D. Summary of Safety and Effectiveness Data Summary of Safety and Effectiveness Data is not a requirement of a Special 510(k). Sec. 807.87 Information required in a premarket notification submission. (j) For submissions claiming substantial equivalence to a device which has been classified into class III under section 513(b) of the act: (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990; and (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in 807.94. This information does not refer to information that already has been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation.

An Active Pharmaceutical Ingredient (API) manufacturer developed and validated a process to manufacture an active ingredient that is used in generic drug products. The API manufacturer is collaborating with three different generic manufacturers who are planning to submit an ANDA for another generic version of the drug. The API manufacturer submitted a Drug Master File (DMF) to FDA to describe the API's chemistry, manufacturing and controls. Which of the following is NOT true regarding the DMF? A. The API Manufacturer can authorize FDA to reference the DMF in the ANDAs of the three generic manufacturers B. Although the DMF is submitted to FDA, it is never approved or disapproved C. The API Manufacturer submits a Type II DMF for the active ingredient D. The API Manufacturer must update the DMF only when the submitted information changes or is no longer accurate

D. The API Manufacturer must update the DMF only when the submitted information changes or is no longer accurate "The holder should provide an annual report on the anniversary date of the original submission. This report should contain the required list ... and should also identify all changes and additional information incorporated into the DMF since the previous annual report on the subject matter of the DMF. If the subject matter of the DMF is unchanged, the DMF holder should provide a statement that the subject matter of the DMF is current. Failure to update or to assure FDA annually that previously submitted material and lists in the DMF remain current can cause delays in FDA review of a pending IND, NDA, ANDA, Export Application, or any amendment or supplement to such application; and FDA can initiate procedures for closure of the DMF (see Section IX)."

A company is sponsoring a Phase 2 clinical study investigating a new drug for treatment of Disease X, which currently affects 190,000 people in the US. Which of the following may a regulatory professional take into consideration if senior management asks about requesting orphan drug designation? A. The new drug would not be eligible for orphan drug designation given the number of people currently affected by Disease X in the US B. The company must demonstrate that Disease X is life-threatening for the new drug to be eligible for orphan drug designation C. Obtaining orphan drug designation is not possible since an IND has already been submitted D. The company must request orphan drug designation before submitting a marketing application for the new drug

D. The company must request orphan drug designation before submitting a marketing application for the new drug According to 21 CFR 316.23, "A sponsor may request orphan-drug designation at any time in the drug development process prior to the submission of a marketing application for the drug product for the orphan indication."

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs practitioner should submit: A. Only the list of all active ingredients, antimicrobial preservatives and antioxidants, with their pharmaceutical grades and the names of the suppliers B. Drug Master File authorization letters from each supplier of active ingredients, antimicrobial preservatives and antioxidants C. GMP Certifications from the suppliers of all active ingredients and excipients D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs practitioner should submit: A. The list of all active ingredients, antimicrobial preservatives and antioxidiants, with their pharmaceutical grades and the names of the suppliers B. Drug Master File referral letters from each supplier of active ingredients, antimicrobial preservatives and antioxidiants C. GMP Certifications from the suppliers of all active ingredients excipients D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs practitioner should submit which of the following? A. The list of all active ingredients, antimicrobial preservatives and antioxidants, with their pharmaceutical grades and the names of the suppliers B. Drug Master File referral letters from each supplier of active ingredients, antimicrobial preservatives and antioxidants C. GMP Certifications from the suppliers of all active ingredients excipients D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product A. This is an incomplete answer according to the regulation. B. See explanation A. C. See explanation A. D. All information required in the regulation is provided. 21 CFR 314.50(d)(1)(ii).

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs practitioner should submit: A. Only the list of all active ingredients, antimicrobial preservatives and antioxidants, with their pharmaceutical grades and the names of the suppliers B. Drug Master File authorization letters from each supplier of active ingredients, antimicrobial preservatives and antioxidants C. GMP Certifications from the suppliers of all active ingredients and excipients D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product

D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product All information required in the regulation is provided; see 21 CFR 314.50(d)(1)(ii).

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs practitioner should submit: A. The list of all active ingredients, antimicrobial preservatives and antioxidants, with their pharmaceutical grades and the names of the suppliers. B. Drug Master File referral letters from each supplier of active ingredients, antimicrobial preservatives and antioxidants. C. GMP Certifications from the suppliers of all active ingredients and excipients. D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product.

D. The list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product. All information required in the regulation is provided. 21 CFR 314.50(d)(1)(ii).

According to the drug regulations, the FDA will most likely put an IND on clinical hold for which of the following reasons: A. Human subjects are exposed to a reasonable degree (non-significant) or risk of illness or injury by participating in the trial. B. The manufacturer charges a fee for the investigational product. C. The clinical investigators are qualified by scientific training or experience to conduct the study described in the investigator's brochure. D. The sponsor is not pursuing marketing approval with due diligence.

D. The sponsor is not pursuing marketing approval with due diligence.

According to the drug regulations, FDA will most likely put an IND study on clinical hold for which of the following reasons: A. Human subjects are exposed to a reasonable degree (non-significant) or risk of illness or injury by participating in the trial. B. The manufacturer charges a fee for the investigational product. C. The clinical investigators are qualified by scientific training or experience to conduct the study described in the investigator's brochure. D. The sponsor is not pursuing marketing approval with due diligence.

D. The sponsor is not pursuing marketing approval with due diligence. The sponsor must be pursuing marketing approval by diligently pursuing timely studies and commercialization per 21CFR312.42.

According to the drug regulations, FDA will most likely put an IND study on clinical hold for which of the following reasons: A. Human subjects are exposed to a reasonable degree (non-significant) or risk of illness or injury by participating in the trial. B. The manufacturer charges a fee for the investigational product. C. The clinical investigators are qualified by scientific training or experience to conduct the study described in the investigator's brochure. D. The sponsor is not pursuing marketing approval with due diligence.

D. The sponsor is not pursuing marketing approval with due diligence. The sponsor must be pursuing marketing approval by diligently pursuing timely studies and commercialization per 21CFR312.42.

According to the drug regulations, the FDA will most likely put an IND study on clinical hold for which of the following reasons: A. Human subjects are exposed to a reasonable degree (non-significant) or risk of illness or injury by participating in the trial. B. The manufacturer charges a fee for the investigational product. C. The clinical investigators are qualified by scientific training or experience to conduct the study described in the investigator's brochure. D. The sponsor is not pursuing marketing approval with due diligence.

D. The sponsor is not pursuing marketing approval with due diligence. The sponsor must be pursuing marketing approval by diligently pursuing timely studies and commercialization per 21CFR312.42.

The title of Code of Federal Regulations that primarily applies to the registration and approval of drugs, biologics and medical devices is: A. Title 42 B. Title 9 C. Title 312 and 314 D. Title 21

D. Title 21

When design validation activities are being performed by a manufacturer, which element is NOT included as a requirement under device design validation section of the QSR? A. Conformance to defined user needs and intended uses B. Testing of production units under actual or simulated use conditions C. Software validation and risk analysis, where appropriate. D. Translation of device design into production specifications

D. Translation of device design into production specifications Translation of device design into production specifications is covered under 820.30(h) Design transfer. Answers A-C are "design validation" activities. Answer 4 is an activity done under "design transfer." Design Transfer is outlined in 21 CFR 820.30(h) and relates to the establishment of procedures to ensure the device design is correctly translated into production specifications. Conformance to defined user needs and intended uses (answer A), testing under actual or simulated conditions (answer B) and software validation and risk analysis are all design validation activities.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) established all of the following EXCEPT: A. Expanded FDA authority for postmarket safety of drugs. B. Reauthorization of prescription drug and medical device user fees. C. Incentives to medical device manufacturers to create devices for children. D. Voluntary registration of clinical trials in FDA database.

D. Voluntary registration of clinical trials in FDA database. FDAAA established mandatory registration of clinical trials in the ClinicalTrials.gov data bank.

You have modified your 510(k) cleared device with a special 510(k). In which of the following cases would you need to create a new device listing for the device? A. You have added new sizes and shapes in the product portfolio. B. You have changed the material composition of the device. C. You have changed the package of the device. D. You have added an additional device under a different name with the same intended use and indication for use but with a minor change to its physical characteristics

D. You have added an additional device under a different name with the same intended use and indication for use but with a minor change to its physical characteristics From 21 CFR 807.22(b): (b) Registration and listing updates. Owners or operators shall review and update all of their establishment registration and device listing information that is on file at FDA, documenting any changes that were not previously reported as follows: (1) Annual registration for each fiscal year is required for all establishments. Annual registration shall take place during the period beginning on October 1 and ending on December 31 of each fiscal year; (2) Updates to the registration information as described in 807.25(b) shall be made within 30 days of any change to such information; (3) Every fiscal year, during the period beginning on October 1 and ending on December 31, owners or operators shall review and update all of their device listing information that is on file at FDA, reporting any changes or deletions to listings and any new listings that were not previously reported. The accuracy of all information on file must be confirmed each year regardless of whether any changes were made to the owner or operator's list of devices; and (4) Changes to listing information may also be made at other times, such as when a device is introduced into commercial distribution, when a change is made to a previously-listed device, or when a previously-listed device is removed from commercial distribution.

Your company is the initial importer of a medical device. Which of the following must be true? A. You must maintain quality assurance files B. You share responsibility for submission with the other distributors C. You must report device malfunctions in an Annual Report D. You must register your company's establishment with FDA

D. You must register your company's establishment with FDA 21 CFR 807.20(a)(4)—Acts as an initial importer as defined in § 807.3(g), except that initial importers may fulfill their listing obligation for any device for which they did not initiate or develop the specifications for the device or repackage or relabel the device by submitting the name and address of the manufacturer. Initial importers shall also be prepared to submit, when requested by FDA, the proprietary name, if any, and the common or usual name of each device for which they are the initial importer.

Which of the following products is required to carry National Drug Code (NDC) number? A. every human prescription drug product B. over the counter drug C. animal drug product D. any drug intended for human or animal use

D. any drug intended for human or animal use Animal drugs also have NDC numbers, but the NDC Directory only lists human drugs. As with a human drug, an NDC number on an animal drug's label does not mean the drug is FDA-approved.

The following type of protocol is not eligible for a Special Protocol Assessment under the PDUFA goals: A. animal carcinogenicity study protocol B. Phase 3 clinical protocol whose data form the primary basis for an efficacy claim C. final product stability study protocol D. bioequivalence study protocol

D. bioequivalence study protocol D. As provided in FDA's Guidance for Industry Special Protocol Assessment (May 2002), BE studies are not part of the PDUFA goals for special protocol assessment.

A 510(k) submission for any Class III device must include a: A. clinical results summary B. hazards analysis evaluation C. stability evaluation D. certification and summary

D. certification and summary

A 510(k) submission for any Class IIl device must include a: A. clinical results summary B. hazards analysis evaluation. C. stability evaluation D. certification and summary.

D. certification and summary. A Clinical data are not required for all Oass III devices. B. Hazards analysis evaluations are not required for Class III devices. C. Stability evaluations are not applicable to all medical devices. D. 51 O(k) for a Class III device must include a Class III certification and summary as defined in 21 CFR 807.3(p and q).

FDA will do a for-cause inspection of an investigator if the investigator: A. conducts a number of pivotal NDA studies B. is only participating in a small number of studies C. appears to have an excessive number of study projects D. consistently reports results different from other investigators

D. consistently reports results different from other investigators A. This is not in violation of the FD&C Act. B. See explanation A. C. See explanation A. D. An inspection will be conducted if an investigator's results are inconsistent with those of other investigators and fraud is suspected. FDA Conduct, Review and Evaluation of Inspections (guidance document).

A clinical study sponsor's representative conducts periodic monitoring site visits for all of the following purposes EXCEPT to: A. review raw data B. ensure compliance with the protocol C. review the protocol with the investigator D. ensure the adequacy of the IRB and its procedures

D. ensure the adequacy of the IRB and its procedures A. These data are included in source documents, which are reviewed by the study monitor. 21 CFR 812.3(j), 21 CFR 812.25(e), 21 CFR 812.43(d). B. This is integral to the monitoring function. 21 CFR 812.46, 21 CFR 312.56, 21 CFR 312.66. C. This step is performed at the study initiation visit and reinforced when necessary. 21 CFR 812.45, 812.46, 21 CFR 312.55. D. An institution conducting clinical investigations is responsible for the integrity of the IRB and is held accountable. There is a degree of confidentiality that may not be breached by a study monitor. The investigator, through the signed 1572 form, assures the sponsor of IRB review. 21 CFR 812.100, 812.110; 21 CFR 312.66, 21 CFR 812.150(a)(2), 812.140(a)(1).

A clinical study sponsor's representative conducts periodic monitoring site visits for all of the following purposes EXCEPT to: A. review raw data. B. audit the adequacy of the study facility. C. review the protocol with the investigator. D. ensure the adequacy of the IRB and its procedures.

D. ensure the adequacy of the IRB and its procedures. A. These data are included in source documents and are integral in the monitoring process. B. This is essential to assessing a clinical investigation and should be done before the study begins and evaluated throughout the study. C. This step is performed at the study initiation visit and reinforced when necessary. D. An institution conducting clinical investigations is responsible for the integrity of the IRB and is held accountable. There is a degree of confidentiality which may not be breached by a study monitor. The investigator, through the signed 1572 Form, assures the sponsor of IRB review.

FDA defines a label as that which is affixed to the: A. carton B. shrink wrapper C. shipping package D. immediate container

D. immediate container A. This is acceptable only if it is the immediate container. B. This is a packaging layer which is exterior to the immediate container. C. This is a package which is not part of the immediate container. D. The term "label" has a narrow meaning limited to the display of written, printed or graphic matter upon the immediate container of an article. 21 CFR 201 (Subpart A).

All of the items below are key provisions of the Medical Device User Fee and Modernization Act EXCEPT: A. user fees for premarket reviews. B. establishment inspections by accredited third party reviewers. C. requirements for reprocessed single-use devices. D. mandatory compliance with ISO 13485.

D. mandatory compliance with ISO 13485. Correct answer. ISO 13485 is the international standard governing the manufacturing of medical devices and has nothing to do with MDUFMA

The Freedom of Information Act allows a manufacturer to: A. make claims about a product already commercially available B. obtain QC methods on a competitor's product C. obtain the Drug/Device Master File of a competitor's product D. obtain public documents on another manufacturer's product

D. obtain public documents on another manufacturer's product A. FOIA does not allow a manufacturer to make claims about a product already commercially available. B. QC methods are confidential and would not be available under FOIA. C. The Drug/Device Master File is also confidential and would not be available under FOIA. D. Public documents on another company's product are available through a written request to the FOIA office.

Which of the following documentation is NOT included in a Biologics License Application? A. stability data B. product labeling C. GLP compliance statement(s) D. overall quality summary

D. overall quality summary A. Required for BLA submission. See 21 CFR 601.2. B. See Explanation A. C. See Explanation A. GLP (included in the tox reports) D. An overall quality summary is a CTD requirement, not a BLA requirement.

For nonclinical studies lasting more than six months, quality assurance audits are conducted at which of the following intervals? A. 1 month B. quarterly C. at completion D. periodically

D. periodically A .Audits should be conducted at intervals appropriate to assure the integrity of the study. D. Periodic auditing by the quality assurance unit is required as appropriate for the study. 21 CFR 58.35(b)(3)

For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at which of the following intervals? A. 1 month B. quarterly C. at completion D. periodically

D. periodically Audits should be conducted at intervals appropriate to assure the integrity of the study (rules out answers A,B and C). Periodic auditing by the quality assurance unit is required as appropriate for the study (21CFR58.35(b)(3)

All of the following are true regarding 21 CFR part 11 except: A. applies to records in electronic form that are created, modified, maintained, and archived for regulatory reasons B. applies to all electronic records submitted to FDA under the FD&C Act. C. part 11 will be interpreted narrowly D. predicate rule record and record keeping requirements are optional.

D. predicate rule record and record keeping requirements are optional. A. 21 CFR part 11 has not been withdrawn. B. 21 CFR part 11 has not been withdrawn. C. Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application. D. Predicate rule record and record-keeping requirements are enforced.

According to regulations and FDA policy for public discussion of unapproved drugs, all of the following are acceptable at a scientific symposium EXCEPT: A. disseminating published scientific articles B. conducting scientific seminars C. recruiting potential investigators D. promoting the drug for its intended use

D. promoting the drug for its intended use A. Articles on preclinical/clinical research may be disseminated if the article does not constitute advertising of an unapproved drug. B. Sessions may be conducted if they do not advertise the product for an unapproved indication and they do not constitute commercialization of product. C. A sponsor may recruit potential investigators at a scientific symposium (i.e., protocol development). D. A manufacturer may not advertise or promote a product for an indication which has not been approved by FDA.

During an FDA post-submission meeting, the regulatory affairs practitioner should attempt to accomplish all of the following EXCEPT: A. identify the individual with primary responsibility for the review B. attempt to reach agreement on acceptability of data C. limit the amount of additional study required D. provide testimonials from investigators

D. provide testimonials from investigators A. Knowing the reviewer will help expedite responses to any inquiries for additional information. B. If more studies are needed, can expedite to provide data required. C. If more studies are needed, have FDA agree on the minimum number. D. FDA approves on basis of adequate and well-controlled studies, not anecdotal statements. 21 CFR 314.126.

During an FDA post-submission meeting, the regulatory affairs practitioner should attempt to accomplish all of the following EXCEPT: A identify the individual with primary responsibility for the review. B. attempt to reach agreement on acceptability of data. C. limit the amount of additional study required. D. provide testimonials from investigators.

D. provide testimonials from investigators. A. Knowing the reviewer will help expedite responses to any inquiries for additional information. B. If more studies are needed, can expedite to provide data required. C. If more studies are needed, have FDA agree on the minimum number. D. FDA makes its approval decision on basis of adequate and well controlled studies, not anecdotal statements. 21 CFR 314.126

Distribution records for drug products must reference or contain all of the following EXCEPT: A. name and address of the consignee B. name, strength and quantity of the product C. control number and date shipped D. purchase order number and date ordered

D. purchase order number and date ordered A. This is required under 21 CFR 211.196. B. See explanation A. C. See explanation A. D. This is not required under 21 CFR 211.196.

Under the official definitions of a "device," all of the following are considered devices EXCEPT: A. X-ray film B. eyeglass lenses and frames C. an in-vitro diagnostic kit D. sterilizers used for device manufacturing

D. sterilizers used for device manufacturing A. This is used for diagnosis of disease and is a medical device. B. These are used in the mitigation of a medical problem (disease) and are medical devices. C. This is used in diagnosis of disease and is a medical device. D. Manufacturing equipment used to produce medical devices are not in themselves considered devices. FD&C Act, Section 201(h)

All of the items below are outlined as responsibilities of clinical investigators EXCEPT: Which of the following is NOT a responsibility of clinical investigators? A. Submits notices to the IRB of deviations from the investigational plan B. Maintaining records of receipt, use and disposition of investigational product C. Reporting to the sponsor withdrawal of IRB approval D. Submitting unanticipated adverse event reports to FDA

D. submitting unanticipated adverse event reports to FDA A. Any changes in investigational plans must have IRB approval and is the investigator's responsibility. B. This is an obligation of the investigator (federal requirement). C. See explanation B. D. This is the responsibility of the sponsor once notified by the investigator, who notifies the sponsor and IRB. 21CFR 312.60, 812.140,150(a) (1). It is the responsibility of the sponsor to notify FDA once notified by the investigator. The investigator is responsible for notifying both the sponsor and the IRB. 21CFR 312.60, 812.140,150(a) (1).

Which of the following documentation is NOT included in a Biologics Product License Application? A. stability data B. product labeling C. GLP compliance statement(s) D. summary basis of approval

D. summary basis of approval The SBA, if required, is prepared after approval.

In preparing the list of components of a drug product to include in an NDA, the regulatory affairs practitioner should submit which of the following? A. the list of all active ingredients, antimicrobial preservatives and antioxidants, with their pharmaceutical grades and the names of the suppliers B. Drug Master File referral letters from each supplier of active ingredients, antimicrobial preservatives and antioxidants C. GMP Certifications from the suppliers of all active ingredients excipients D. the lis tof all components used in the manufacture of the drug product, regardless of whether theyappearin the drug product

D. the list of all components used in the manufacture of the drug product, regardless of whether they appear in the drug product A. This is an incomplete answer according to the regulation. B. See explanation A C. See explanation A D. All information required in the regulation is provided. 21 CFR 314.50(d)(l)(ii)

An NDA is required to contain copies of case report forms for each patient who had: A. to be hospitalized B. a serious adverse event C. one unexpected adverse event D. to drop out because of an adverse event

D. to drop out because of an adverse event A. Reporting of these events is required during the investigational stage (312.32) and postmarketing (314.80)(a). (Note: regulations do not state that these reports need to contain case report forms.) D. Case report forms for these patients are required.

According to the QSR, Design Outputs contain the following: A) The Device Master Record (DMR) B) The documentation from the last phase of the complete Design Control process C) The test reports that support that the Design Inputs have been met D) All of the packaging and labeling associated with the finished device E) A and D above

E) A and D above NOT RAC TEST STYLE QUESTION Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record

From a pre-clinical viewpoint, which of the following constitute pre-clinical activities in medical device development? A) Animal use testing to validate the design of your device B) Bench testing to verify that your design performs as designed C) Biocompatibility/Toxicity testing D) Functional/Safety/Performance testing E) All of the above

E) All of the above NOT a RAC test style question Pre-clinical refers to any testing NOT performed in a human being.

According to the QSR, Quality Audits must accomplish the following: A) Meet the same requirements of the original GMP B) Evaluate if the Quality System is in compliance with the QSR C) Determine the effectiveness of the Quality System D) Focus on Design Controls and the CAPA system E) B and C above F) A and D above

E) B and C above B) Evaluate if the Quality System is in compliance with the QSR C) Determine the effectiveness of the Each manufacturer shall establish procedure for quality audits and conduct such audits to assure that the QS is in compliance with the established QS requirements and to determine the effectiveness of the QS. Quality System FDA investigators may review the schedule for your internal audits but are not supposed to ask to see the audit results From the QSIT Manual: Review the firm's quality audit schedules to assure quality audits are being conducted with sufficient frequency. It is recommended that the time between quality audits not exceed a 12-month period. More frequent audits may be recommended if the firm has a serious Quality System Regulation problem. Evidence of inadequate auditing may exist without gaining access to the written quality audit reports.

A moderate change to the ANDA may be submitted to the FDA in the annual report: True or False

FALSE

Cosmetic manufacturers are required to test the safety of their products: True or False

FALSE

It is not necessary to respond in written to a Warning Letter: True or False

FALSE

The Freedom of Information Act prohibits FDA from preventing the release of FDA-generated records: True or False

FALSE

Veterinary drugs are regulated under the Center for Drug Evaluation and Research (CDER), because the requirements for approval are the same: True or False

FALSE

Some in vitro diagnostics are regulated by CDER. True or False

FALSE IVDs are regulated by CDRH or by CBER, depending on the specific device

Orphan Drug Applicants need not follow the standard drug approval process for approval True or False

False FDA's requirements for the drug development pathway resulting in NDA approval for orphan drugs (or applications for other products) are the same as for other drugs.

Orphan drug designation for an indication can be obtained after submission of a marketing application for the same drug and same indication. True or False

False In 1988, an amendment to the Act changed the requirement for submitting applications for orphan drug status. Under the revised Act, the application for Orphan Drug Designation now has to be made prior to the submission of an application for marketing approval, New Drug Application (NDA) or Product License Application (PLA).

Submitting a request for Orphan status is the same as obtaining a fast track status. True or False

False There is no fast-track process to get orphan drugs approved quicker than other drugs; however because most orphan drugs are for life-threatening illness they tend to go through the approval process faster.

All of the following are considered raw data in a preclinical study EXCEPT: A. Final Pathology Report B. Records of quarantine and animal receipt C. Animal data entered into the animal chart D. Computer printout derived from data transferred to computer media from lab data sheets

Raw data are defined as "any laboratory worksheets, records, memorandum, notes that are the result of original observations and activities and are necessary for the reconstruction and evaluation of the report of that study."