FINAL 439

A medical science liaison (MSL) employee for your company meets with a physician on a Wednesday to discuss a post-market study for your approved drug. The physician mentions to the MSL at that meeting that he had a patient that was recently hospitalized for a seizure disorder after taking your drug. The MSL was traveling back to the home office following their meeting and reports this information to your company medical information (MI) department the following Monday. Which of the following is true regarding this situation (select all that apply)? A. If this were found to be a serious and unexpected adverse event, it would have to be reported to the FDA on the same Monday it was reported to your company MI department B. Day zero for FDA reporting purposes will be the Monday it was reported to your company MI department C. Day zero for adverse event reporting purposes is the Wednesday that the MSL met with the physician D. This is a serious adverse event report and if found to be unexpected would require expedited reporting to the FDA

- Day zero for adverse event reporting purposes is the Wednesday that the MSL met with the physician - This is a serious adverse event report and if found to be unexpected would require expedited reporting to the FDA

What are the components of plasma product safety?

1. Donor Quality 2. Manufacturing pool quality 3. Fractionation Process

When communicating a product quality issue to customers which of the following information should be included? A. Statement of the problem and potential consequences B. Company contact person C. Instructions regarding actions to be taken D. All of the above

1. Statement of the problem and potential consequences 2. Company contact person 3. Instructions regarding actions to be taken

A Pre-Approval FDA Inspection of a Sponsor's manufacturing facility would likely include which of the following select all that apply)? A. Verification of clinical study efficacy endpoint measures B. Verification of the accuracy and completeness of the information and documentation related to the manufacturing process C. Compliance and adherence to cGMPs D. Evaluation of manufacturing controls and pre-approval drug batches

1. Verification of the accuracy and completeness of the information and documentation related to the manufacturing process 2. Compliance and adherence to cGMPs 3. Evaluation of manufacturing controls and pre-approval drug batches

What does good promotional material look like?

1.Product brand & Generic Names 2. Balance of risk/benefits of product 3. Graphic & written representation consistent with labeling

how long does plasma derived manufacturing take?

7-12 months

At what temp can HIV be deactivated in plasma ?

80C

A New Drug Application must always provide which of the following for FDA approval (select all that apply) A. Demonstrate that the drug is safe and effective (show substantial evidence) B. Evidence that the drug manufacturing process and controls used maintain drug quality C. Superiority over another drug on the market approved for the same indication D. Demonstrate that drug benefits outweigh risks for use in the indication under consideration

A. Demonstrate that the drug is safe and effective (show substantial evidence) B. Evidence that the drug manufacturing process and controls used maintain drug quality D. Demonstrate that drug benefits outweigh risks for use in the indication

Marketed product quality problems may be identified from which of these common sources (select all that apply)? A. Journal articles and conference presentations B. Complaints from healthcare professionals, patients and consumers C. Reports of problems from other countries where the product is marketed D. Preclinical testing in animal models

A. Journal articles and conference presentations B. Complaints from healthcare professionals, patients and consumers C. Reports of problems from other countries where the product is marketed

Which of the following are common violations identified by the OPDP that may result in warning or untitled letters (select all that apply)? A. Making unsubstantiated claims including superiority claims B. Promoting unapproved uses C. Overstating risk and safety information D. Minimizing risk information

A. Making unsubstantiated claims including superiority claims B. Promoting unapproved uses D. Minimizing risk information

A patient has contacted your company with a complaint about your marketed product. They were recently hospitalized and the patient thinks that their last prescription of the product was not as effective at treating their seizures as the previous prescription. She was told by her physician that she suffered a different type of seizure than she has had before. Which of the following would apply to thissituation (select all that apply) A. Your drug safety Department will need to determine whether this complaint also represents a serious and unexpected adverse drug experience B. There is no evidence of any connection between the hospitalization and the patient's concern and, therefore, this is not a quality issue and no further follow-up or reporting is required C. This will need to be reported as a product quality complaint to your Quality Department and reported as a lack of adverse event report to the FDA D. This will only need to be reported as a product quality complaint to your Quality Department.

A. Your drug safety Department will need to determine whether this complaint also represents a serious and unexpected adverse drug experience. C. This will need to be reported as a product quality complaint to your Quality Department and reported as a lack of adverse event report to the FDA

What is currently being used to treat Hemophilia A

Adynovate

Promotional marketing must contain a fair balance. Depending on the type of material, fair balance may include one or more of the following (select all that apply)? A. Prescribing Information for Help-Seeking Ads B. Brief Summary in the case of consumer print ads C. "Adequate Provision" in the case of Direct to Consumer TV ads D. ISI in the case of sales detail aids

B. Brief Summary in the case of consumer print ads C. "Adequate Provision" in the case of Direct to Consumer TV ads D. ISI in the case of sales detail aids

505(b)(2) New Drug Applications are more common in which of the following situations (select all that apply) A. A first-in-class New Drug Application for a drug not previously marketed anywhere in the world B. Creating a new dosage form that is faster acting than a currently marketed product C. Seeking approval for a new indication for an already-approved product D. Carrying out an Rx-to-OTC product switch

B. Creating a new dosage form that is faster acting than a currently marketed product C. Seeking approval for a new indication for an already-approved product D. Carrying out R-to-OTC product switch

You have just received a "Complete Response Letter" from the FDA. Which of the following best describes the FDA's assessment of your New Drug Application. Select the SINGLE best answer A. The FDA has approved your New Drug Application as long as you monitor for adverse events of special interest ! B. The FDA will not approve your New Drug Application in its present form and you will need to take action which may include resubmission addressing deficiencies, request a hearing to discuss next steps and/or withdrawal of your application ! C. Your New Drug Application has been approved for marketing as of the date of the letter ! D. The FDA refuses to approve your New Drug Application and a list of deficiencies are provided

B. The FDA will not approve your New Drug Application in its present form and you will need to take action which may include resubmission addressing deficiencies, request a hearing to discuss next steps and/or withdrawal of your application !

Your company's marketing department would like to develop a reminder advertisement campaign for your newly approved product for use in the treatment of adults with insomnia. They chose a reminder ad approach so that the ad will not have to include the black box warning or any other risk information. They plan to include the drug Trade Name and generic name, a graphic of sheep jumping over the bed of a sleeping adult, and an "ask your doctor about" call to action. Which of the following would you include in your response to marketing (select all that apply)? A. I think we can make this work as long as you remove the call to action statement B. You cannot be serious, reminder ads are not allowed for drugs with black box warnings C. Whatever, I've seen worse marketing ideas D. Reminder ads cannot make any representations or claims regarding drug use or effectiveness - the sleeping adult and sheep must go!

B. You cannot be serious, reminder ads are not allowed for drugs with black box warnings D. Reminder ads cannot make any representations or claims regarding drug use or effectiveness - the sleeping adult and sheep must go!

quality section= CMC. What does CMC stand for?

Chemistry, Manufacturing, Controls

Which of the following would typically be the first step in the evaluation of a product complaint (Select the single best answer)? A. Complaint failure investigation B. Business Impact C. Health Hazard Evaluation D. Corrective/ preventative action development for the root cause

Complaint failure investigation

2. Generic drug applications are termed "abbreviated" because they always require animal and human clinical data to support safety and effectiveness. True or False?

FALSE

The reporter of a product quality complaint should always be instructed to discard the product. True or False.

FALSE

A post approval submission where the only change to the prescribing information is to strengthen the product safety information will always fall under the reporting category of a PAS. True or False

False

For a 505(b)(1) New Drug Application, supporting data would be predominantly obtained from studies conducted outside of the U.S. true or False

False

Which of the following ICH Guidance Documents are you likely to find guidance on the CTD sections for clinical data overview/ summary and the clinical study reports A. M4Q B. M4S C. M4E D. M4(R3)

M4E

What are some fact about Immunoglobulin G (Ig G)

Most abundant class in serum, 80% total immunoglobulin, contain less carbs than other Igs, longer half-life.

The written record for product quality complaint files shall include which of the following? select all that apply A. Name and strength of the product B. Lot number of the product C. Reply to the complaint D. The name of the complainant and nature of the complaint

Name/strength of the product, lot number, reply to complaint, name of complaint and nature of complaint

Which of the following would NOT represent a product quality complaint? A. A product suspected of being a counterfeit B. A product labeling issue resulting in a medication error C. Dissatisfaction with the way an orally administered product tastes D. None of the above

None

Which of the following FDA reporting categories would be used for a post approval change to a marketed product that has substantial potential for adverse impact and where the change can only be made after receipt of FDA approval ? A. PAS B. CBE-30 C. CBE D. AR

PAS

Who are the PRC and what do they do?

Promotional Review Committee; Review's company promotional material and makes sure it is withing compliance to the law/regulations.

What is the future treatment of Hemophilia A

Recombinant Antihemophilic Factor and Gene Therapy

3. An ANDA must show that the human use described in proposed labeling has been previously approved for a listed drug covered by an NDA. True or False

True

A 505(b)(2) New Drug Application requires full reports of investigations of safety and effectiveness but some of the information required for approval comes from studies not conducted by or fir the applicant. True or False?

True

A 505(j) New Drug Application is also referred to as an ANDA. True or False?

True

A Field Alert Report must be submitted to the FDA if the product is found to have bacterial contamination. True or False?

True

A class I recall is an emergency situation involving removal from the market of a product in which the consequences are immediate or long-range, life threatening, and involves a direct cause-effect relationship. True or false?

True

A post approval submission for implementation of a computer manufacturing process control to replace a manual process would likely fall under the reporting category of either CBE or CBE-30. True or False

True

Special situations that need to be reported to the drug safety department, whether or not associated with an adverse event, such as pregnancy or lactation exposure, overdose, abuse or misuse represent important sources of potential risk and safety information not usually identified in clinical trials. True or False

True

The FDA Guidance Document concerning the Common technical Document (CTD) used to help prepare an NDA does not address the scientific and technical content of the CTD. True or False

True

The Scientific and technical content requirements for the CTD are covered by the International Conference on Harmonization Guidance Documents. True or False

True

What is the cause of hemophilia A? and what are the signs?

X-linked genetic disorder; only male affected. signs: prolong bleeding, spontaneous bleeding, bleeding into muscles and joints

what was the downside of liquidized drug baxter

couldn't administer it in the same place.

What is the relative risk from donor selection to finished product?

donor has the highest risk and finished product has no risk at all.

history of viral transmission by plasma derivatives

half of people with hemophilia became infected with HIV, many developed AIDS

How can you reduce infusion time?

increasing concentration

What is blood plasma consist of?

mostly water, with solutes dissolved in it.; glucose, waste, protein

Field Alert Reports must be submitted to the FDA within 3 calendar days. True or False?

true ; reported immediately