JP Exam #1 (Chapter 2)

What law prohibited the adulteration and misbranding of foods and drug in interstate commerce?

The Pure Food and Drug Act of 1906

The Drug Price Competition and Patent Term Restoration Act is also known as what?

The Waxman-Hatch Amendment

What event prompted the Federal Anti-Tampering Act?

The intentional contamination of Tylenol capsules on retailer's shelves in 1982

If a manufacturer gets approval for an INDA what does this allow the manufacturer to do?

The manufacturer may conduct clinical studies of its investigational new drug

What event prompted the passage of the FDCA in 1938?

The sulfanilamide elixir tragedy of 1937

What does a black box warning found within a package insert indicate?

The use of the drug may lead to death or serious injury

What was the intent of the Drug Price Competition and Patent Term Restoration Act?

To make generic drugs more readily available to the public and to provide incentives for manufacturers to develop new drugs

What is the intent of the FDCA?

To protect consumers from adulterated or misbranded foods, drugs, cosmetics or devices.

Although the Pure Food and Drug Act of 1906 helped to address the problems with adulteration and misbranding, it did not prevent false or misleading efficacy claims. This was made apparent by what case?

US v. Johnson (1911) [Court ruled misbranding provisions in the law prevented false statements only as to the drug's identity (i.e.. strength, quality, purity)]

A single dosage unit of a drug is prepackaged and prelabeled for direct administration.

Unit dose packaging

________ health claims are allowed if authorized by the FDA pursuant to the significant scientific agreement test.

Unqualified

In 2010 the FDA implemented the _______ _______ ______, with the intent of enlisting health care professionals to help ensure that company promotion of prescription drugs is truthful.

"Bad Ad Program" *one year after the program's implementation, the FDA announced complaints against drug companies had TRIPLED!

An online information clearinghouse through the National Library of Medicine. Its objective is to provide the most up-to-date medication info. to consumers and health care professionals.

"DailyMed"

Foods or nutraceuticals that have been fortified or enhanced, often w/ dietary supp., such as drinks w/ ginseng or kava kava added to foods fortified w/ calcium.

"Functional Foods"

In the ___________ section of the package insert you can find the most important information about a product, such as boxed warnings, indications for usage and dosage and administration information.

"Highlights"

Established that corporate officials can be personally prosecuted w/out proof they acted intentionally or with negligence and even if they had no knowledge of the offense.

"Park Doctrine"

For some OTC drug products, manufacturers publish additional labeling specifically for the health care professional, not the consumer. What is this called?

"Professional labeling" [it is intended to provide info for conditions not appropriate for lay diagnosis or treatment]

What disclaimer must be on all dietary supplements in order for them to be able to make any of the 4 allowed statements?

"This statement has not been evaluated by the FDA. This product is not intended to diagnoses, treat, cure or prevent any disease."

"directions under which the layperson can use a drug safely and for the purposes for which it is intended"

"adequate directions for use"

Practice that involves an innovator manufacturer producing a generic version of its brand-name product

"authorized generic"

1. articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, etc.

"cosmetic"

Means in instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, etc.

"device"

1. articles recognized in the USP, official Homeopathic Pharmacopeia of the US, or official National Formulary, or any supplement to any of them 2. articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals 3. articles (other than food) intended to affect the structure or any function of the body of man or other animals 4. articles intended for use as a component of any articles specified above

"drug"

What law granted the FDA authority to regulate tobacco products?

Family Smoking Prevention and Tobacco Act

What law makes it a federal offense to tamper with consumer products?

Federal Anti-Tampering Act

1. articles used for food or drink for man or other animals 2. chewing gum 3. articles used for components of any such article

"food"

A drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling.

"new drug"

Under this policy, a generic drug manufacturer would not have to duplicate the actual research establishing the safety and efficacy of the innovator drug, as a full NDA would require. Rather, the generic drug manufacturer could submit evidence of its drug's safety and efficacy on the basis of published scientific data generated from the innovator manufacturer's studies...this caused quite an uproar from innovator drug manufacturers.

"paper" NDA

The FDAAA granted the FDA an important safety tool called ______________, whereby the FDA can require a drug product sponsor to establish special procedures directed at patient safety.

"risk evaluation and mitigation strategy" (REMS)

Findings of adequate and well-controlled investigations by experts qualified by scientific trying and experience to evaluate the drug's effectiveness.

"substantial evidence"

Category ____ includes ingredients generally recognized as safe, effective and not misbranded

1

A patients consent must be in WRITING for phases ____ & ____, but may be oral for phase _____.

1 & 2 3

Manufactorurers, packers, or distributors whose name appears on the label must also submit any subsequent medical info. received within _______ of the initial reported event.

1 year

The Medical Device Amendments require what 5 things?

1. Classification of devices according to their function 2. Premarket approval 3. Establishment of performance standards 4. Conformance w/ GMP regulations 5. Adherence to record & reporting requirements

The Food and Drug Admin. Mod. Act of 1997 was passed primarily to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. What else did this act do?

1. Created a fast-track approval process for drugs intended for serious or life-threatening diseases. 2. Established a databank of info. on clinical trials. 3. Authorized scientific panels to review clinical investingations. 4. Expanded the rights of manufacturers to disseminated unlabeled use info. 5. Expanded FDA's authority over OTCs. 6. Established ingredient-labeling requirements for inactive ingredients. 7. Also affected the regulation of medical devices.

What are the 4 types of certification a generic applicant can make relevant to the patent of the reference drug under the PTRA?

1. NDA holder did not file info on the patent to the FDA 2. Patent already had expired 3. Date that the patent will expire 4. Patent is invalid or will not be infringed by the manufacture, use or sale of the generic drug

"Adequate" labeling of an OTC drug must include (6):

1. QUANTITY or DOSAGE for each intended use and for persons of different ages and physical conditions 2. FREQUENCY of admin./application 3. DURATION of admin./application 4. TIME of admin./application 5. ROUTE of admin./application 6. PREPARATION necessary for use (i.e. shaking, etc.)

The Kefauver-Harris Amendment made the efficacy requirement retroactive to all drugs marketed between 1938 and 1962. The amendment also accomplished 3 other things, which were what?

1. Transferred jurisdiction of prescription drug advertising from the FTC to the FDA 2. Established GMP requirements 3. Added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of ADRs

What 2 things did the Drug Price Competition and Patent Term Restoration Act (PTRA) do for innovator drug manufacturers?

1. allowed FDA to grant innovator drugs PATENT-TERM EXTENSIONS 2. provided MARKET EXCLUSIVITY for an innovator manufacturer that develops a new chemical entity or a new use for a previously approved drug

An approved drug may become a new drug if what? (5)

1. drug contains a new substance (ie. active ingred., excipient, carrier, coating) 2. new combination of approved drugs 3. proportion of ingred. in combo. is changed 4. new intended use for the drug 5. dosage, method, or duration of admin./application is changed

"Adequate" labeling of a prescription drug must include (6):

1. drug's INDICATIONS 2. AEs 3. DOSAGES 4. ROUTES, METHODS, FREQUENCY, DoA 5. CONTRAINDICATIONS 6. Other warnings/precautions that enable a practitioner to administer, prescribe or dispense the drug safely

_______ are defined as live microorganisms that when administered in adequate amounts produce healthy results.

Probiotics

Regulations require a label on the UNIT DOSE container to include...

1. established drug name 2. quantity of the active ingred. in each dosage unit 3. expiration date 4. lot or control number 5. name/place of business of manufacturer, packer or distributor 6. any other required statements

A product is an imitation if it is... (3)

1. identical in shape, size and color 2. similar or virtually identical in gross appearance 3. similar in effect to controlled substances

A rating of P indicates that the drug may represent a therapeutic advance for one or more of these reasons: (3)

1. no other effective drugs are available 2. more effective or safe than drugs currently used 3. has important advantages (ie. greater convenience, reduced AEs, etc.)

What 4 statements does DSHEA allow dietary supp. suppliers to make w/out fear that the statements would cause the FDA to consider their product a drug?

1. product will benefit a classical nutrient deficiency disease, as long as it also discloses the prevalence of the disease in the US 2. role of the dietary supp. in affecting the structure/function of the body 3. documented mechanism 4. general "well-being" statements **manufacturer has 30 days to notify FDA that they have made this statement

The Pure Food and Drug Act of 1906 did not require the label to list what?

1. the ingredients 2. include directions for use 3. provide warnings *the Act also failed to regulate cosmetics or devices

How many numbers are in each NDC?

11

The BPCIA grants a ____ year marketing exclusivity period to the reference product.

12 year

Manufactorurers, packers, or distributors whose name appears on the label must submit to the Secretary of Health and Human Services (through MedWatch) any report of a serious AE within ____ business days.

15

By statute, the FDA has ____ days in which to act on a completed NDA, but significant delays are common.

180 days

To encourage generic manufacturers to challenge patents, since to do so is very costly, the law awards _____ days of marketing exclusivity to the first generic applicant to file an ANDA containing a paragraph 4 certification.

180 days

Prior to the PTRA the FDA would accept ANDAs for generic drug equivalents marketed between ___ and ___, it did not accept ANDAs for generic equivalents marketed after ____.

1938 - 1962 1962

The first segment of the NDC corresponds to what? The second? The third?

1st: manufactorer or distributer 2nd: specific strength, dosage form and formulation of a particular form 3rd: package size and type of drug

Category ____ includes those ingredients that are not generally recognized as safe and effective or that are misbranded

2

Manufactures are inspected but the FDA for compliance with CGMP once every ____.

2 years

Category ____ includes ingredients for which data available are insufficient to permit classification

3

Any devices NOT marketed before 1976 initially fall into class ____, unless the FDA determines that they are substantially equivalent to a class ___ or ___ device.

3 1 or 2

If the FDA does not reject the IND request within ____ days of submission, human clinical testing may begin.

30

About how many prescription drugs contain BBWs?

450

For new chemical entities approved under an NDA, the market exclusivity provision prevents a generic drug application from being submitted for ___ years from the date of approval of the drug. For a new use for a previously approved drug, the PTRA grants ___ years exclusivity against an ANDA.

5 years 3 years

Some generic manufacturers have used the __________ process to obtain market approval when their generic drug does not qualify for ANDA submission b/c the dosage form or route of admin. varies from the pioneer drug.

505(b)(2) application

What replaced the old paper NDA?

505(b)(2) application

The FDA is allowed to exempt a drug from the NDA requirement for the pursuit of clinical investigations; however the manufacturer must apply for what?

A "Notice of Claimed Investigational Exemption for a New Drug" AKA: Investigational New Drug (IND) Application

Under an ______, proof of safety and efficacy was not required but rather only proof of bioequivalence and proof of acceptable manufacturing methods and controls.

ANDA (abbreviated new drug application)

The FDCA also expanded the definitions of misbranding and adulteration and required labels to contain what?

Adequate directions for use and Warnings about the habit-forming properties of certain drugs

What Act provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA?

FDCA of 1938

________ can include chemical and non chemical entities, and in fact most anything.

Articles

The ______ grants the FDA the authority to determine whether a biosimilar is therapeutically equivalent to a reference biologic and thus can be substituted in the same manner as generic drug products.

BPCIA (Biologics Price Competition and Innovation Act)

_______ are products derived from living organisms. (ex: viruses, toxins, antitoxins, etc.)

Biologics/biologicals

______ devices require the least regulation b/c they pose the least potential harm to users, therefore "general controls" are adequate to ensure safety and effectiveness (ex: needles, toothbrushes, stethoscopes)

Class 1

______ devices must meet specific performance standards established by the FDA before the FDA will permit marketing. Examples include insulin syringes, infusion pumps, thermometers, etc.

Class 2

______ devices must have premarket approval b/c they are life-supporting or life-sustaining or they present unreasonable risk of illness or injury. Examples include pacemakers, soft contact lenses, and replacement heart valves.

Class 3

_________ recalls are issued when there is a reasonable probability that the product will cause serious, adverse health consequences or death.

Class I

_______ recalls occur when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote.

Class II

_______ recalls apply to products that are not likely to cause adverse health consequences.

Class III

What amendment to the FDCA required manufacturers to establish the safety of color additives in foods, drugs and cosmetics? Also contains a Delaney Clause as well.

Color Additive Amendment of 1960

A set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product.

Current Good Manufacturing Practice (CGMP)

What is an anticancer provision commonly known as?

Delaney Clause

The FDA is a component of what department?

Dept. of Health and Human Services (DHHS)

What law defines dietary supps. and permits manufacturers to make certain claims that otherwise would have been illegal under the FDCA. This forced the FDA to regulate dietary supps. more as foods than drugs.

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Under ________, the FDA changed its policy and regarded generic drugs as new drugs, and required manufacturers to prove efficacy.

Drug Efficacy Study Implementation (DESI)

This was enacted by Congress in 1984 to streamline the generic drug approval process while giving patent extensions, in certain cases, to innovator drugs.

Drug Price Competition and Patent Term Restoration Act

The _______ ________ established two classes of drugs, prescription and OTC, and provide that the labels of prescription drugs need not contain "adequate directions for use" so long as they contain the legend, "Caution: Federal law prohibits dispensing without a prescription."

Durham-Humphrey Amendment [the amendment also authorizes oral prescriptions and refills for prescription drugs]

What does ETASU stand for?

Elements To Assure Safe Use

T or F: Currently the law recognizes categories of nutraceuticals and functional foods.

FALSE!! The law does not recognize any category of articles as nutraceuticals or functional foods.

T or F: A tamper-resistant package and a tamper-proof package are the same thing.

FALSE!! There is no such thing a tamper-proof.

T or F: Premarket approval from the FDA is necessary for a cosmetic.

FALSE!! it is not necessary

T or F: All marketed drugs today have been approved by the FDA.

FALSE!!!

T or F: The FDA acknowledged that between 1973 and 1983 only 20 products were approved for the treatment of rare diseases.

FALSE!!! only 10 products were approved

T of F: Prescription drugs are labeled for the patient.

FALSE!!! Prescription drugs are labeled for the HEALTH CARE PROFESSIONAL, not the patient.

The ______ amended the FDCA to require that NDA sponsors must publish summary info about any post phase 1 clinical trial on a public registry.

FDAAA [prior to this, sponsors only had to post clinical study info for drugs intended to treat serious or life-threatening disease]

What law allows the FDA to continue to collect user fees for generic drugs and biosimilars? This law also is directed at reducing drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages and enhancing the exchanged of prescription drug diversion info. across state lines. Under this law the FDA can inspect foreign drug manufacturers more regularly.

FDASIA of 2012

This website will offer one-stop access for info. about all FDA-regulated products.

Facts@FDA

The _______ act has a more important role in protecting the consumer against false and misleading advertising than then _____ act.

Federal Trade Commission Lanham Trademark

What amendment to the FDCA requires that components added to food products must receive premarket approval for safety? Also contains an anticancer provision which prohibits the approval of any food additive that might cause cancer.

Food Additives Amendment of 1958

What act provides for the comprehensive regulation of all drugs introduced into interstate commerce?

Food, Drug and Cosmetic Act (FDCA) of 1938

A committee designated by the institutions charged w/ reviewing any research projects involving human subjects.

Institutional Review Board (IRB)

If a clinical study is to take place in an institutional setting, the local _________ must approve the study.

Institutional Review Board (IRB)

What amendment to the FDCA strengthened the new drug approval process by requiring that drugs be proved not only safe but also effective?

Kefauver-Harris Amendment

______ refers to information required on the container or wrapper.

Label

Explain the concept of "direct regulation".

Making decisions for people rather than helping them to make decisions themselves.

Foods formulated for oral use under the supervision of a Dr. that are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation.

Medical foods Ex: foods formulated w/out phenylalanine for phenylketonuria, folic acid, etc.

Includes foods that provide health or medical benefits, including the prevention and treatment of disease.

Nutraceuticals

What law mandates nutrition labeling on food products and authorizes health claims on product labeling, as along as they are made in compliance w/ FDA regulations?

Nutrition Labeling and Education Act of 1990 (NLEA)

Allowed food labeling to contain a health or disease-prevention claim, but only if the FDA had promulgated a regulation approving the claim and establishing the conditions under which the claim can be used.

Nutrition Labeling and Education Act of 1990 (NLEA) [NLEA can now permit health claims w/out requirement that the FDA must issue a regulation, as long as there is "significant scientific agreement"]

What law focuses on informed decisions by patients rather than on decisions by gov. or health care providers on behalf of the patients?

OBRA '90

What did Congress pass in order to provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of "rare diseases or conditions" (defined as those affecting fewer than 200,000 Americans)?

Orphan Drug Act of 1983

For therapeutic potential, the FDA uses the letters P for ______ or S for _______.

P for priority S for standard

Unlike drugs, biologicals are licensed under the _____.

PHSA (Public Health Service Act)

This phase involves a small # of subjects. Investigators exam the drug's toxicity, metabolism, BA, elimination and other pharmacological actions.

Phase 1

Phase ____ involves the drug being tested on a limited # of patients who actually have the disease for which the drug is an intended treatment.

Phase 2

Phase ____ involves the drug being tested for safety and efficacy in hundreds or even thousands of patients.

Phase 3

This law establishes sales restrictions and record keeping requirements for prescription drug samples. It also prohibits hospitals and other health care entities from reselling their pharmaceutical purchases to other businesses and requires the state licensing of drug wholesalers.

Prescription Drug Marketing Act of 1987

This law requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies.

Prescription Drug User Fee Act of 1992 (PDUFA)

When a product nears its patent expiration, a manufacturer may make some type of product change, such as ER or a different salt, and secure an additional patent.

Product hopping

________ health claims may be made when the claim doe not meet the significant scientific agreement test and the claim would be misleading w/out the qualification. These will be allowed when there is more evidence for the claim than against it. These must be truthful and not misleading and appropriately indicate the level of scientific support. (ie. "scientific evidence suggest but does not prove").

Qualified

Call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product.

Reminder advertisements

An _____ rating means that the drug may have therapeutic properties similar to those of drugs already on the market and offers at best only minor improvements over existing drug therapies.

S (standard)

Proactive surveillance system designed to detect early signs of medication risk and safety problems. Because of this the FDA is developing a new electronic system that will enable it to query a broad array of info data sources to identify possible postmarket AEs.

Sentinel Initiative

What are special dietary foods? What are some examples?

Special dietary foods are those supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition. Ex: infant formulas, caloric supplements

T or F: An approved drug may become a new drug.

TRUE

T or F: New OTC drug products that conform to the published monograph requirements may be marketed w/out FDA approval.

TRUE

T or F: The FDA may terminate the testing of an IND at any time if studies show that the drug is too toxic under the agency's benefit/risk ratio criteria.

TRUE

T or F: The FDCA excludes from the definition of dietary supp. any article that was approved as a new drug, unless prior to the approval it was marketed as a dietary supplement or food.

TRUE

T or F: The FDCA exempted drugs marketed before 1938 from the requirement that new drugs be proven safe before being marketed.

TRUE

T or F: Under the Color Additives Amendments, the FDA can approve a color for one use but not for others (i.e. external use only).

TRUE

T or F: Prior to the FDAAA, the FDA did not have the authority to require manufacturers to include additional safety info or warnings in its labeling AFTER the drug had been marketed.

TRUE FDAAA provided the FDA the authority to compel safety-related labeling changes when the FDA becomes aware of serious drug risk that it believes should be included in the labeling.

T or F: A pharmacy may be deemed a manufacturer if it repackages or compounds medications for sale under certain conditions.

TRUE!!

T or F: DSHEA generally prohibits the FDA from regulating dietary supps. as food additives as well.

TRUE!!

T or F: If therapeutic or structure/function claims are made, an article is a drug, no matter what.

TRUE!!

T or F: The FDA cannot require premarket approval of dietary supplements as they do for drugs.

TRUE!!

T or F: The actual authority for administering the FDCA is vested with the secretary of DHHS.

TRUE!!

T or F: The presence of the NDC number one the label or labeling does not indicate that a drug has received an approved NDA.

TRUE!!

T or F: Cosmetic manufacturers do not have to conform to current GMPs or even register with the FDA.

TRUE!!...registration is voluntary

_________ is defined as improper interference w/ a product for the purpose of making objectionable or unauthorized changes.

Tampering

This law adds 2 parallel mandatory serious adverse events reporting systems: one for nonprescription drugs and the other for dietary supps.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act

The Kefauver-Harris Amendment is also known as what?

The Drug Efficacy Amendment

This law authorizes the FDA to ban individuals or firms from participating in the drug approval process if convicted of false statements, bribes, failures to disclose material facts, etc.

The Generic Drug Enforcement Act of 1992

What novel described atrocious adulteration problems in the meat industry?

The Jungle by Upton Sinclair

Prohibits the use of "any false description or representation, including words or symbols"

The Lanham Trademark Act

What federal law allows private parties a cause of action against false and misleading advertising?

The Lanham Trademark Act

The Durham-Humphrey Amendment is also known as what?

The Prescription Drug Amendment

The novel The Jungle was most closely associated with what act passed by Congress in 1906?

The Pure Food and Drug Act of 1906

It is a _________ violation if a drug is an imitation of another drug.

misbranding

Whereas __________ deals w/ a drug's strength, purity and quality, ___________ focuses on representations made by the manufacturer on the label or labeling.

adulteration; misbranding

If the literature is deemed not to accompany the product, it is _______.

advertising

Why does the FDA not allow professional labeling on the labeling of the marketed OTC product?

because it does NOT contain "adequate directions for use"

In the FDA classification system, a number indicates the drug's _________ and a letter indicates its __________.

chemical type; therapeutic potential

Before the FDAMA, section 502 contained a provision stating that the labeling of any drug found to be habit-forming must contain a warning label to this effect. The FDAMA deleted this provision, thus making the warning discretionary w/ the manufacturer. However manufacturers are still required to do what?

describe the habit-forming characteristics of the drug in the "Drug Abuse and Dependence" section of the package insert

A _______ does not achieve any of its principal intended purposes through chemical action and is not dependent on being metabolized for the achievement of any of its principal intended purposes.

device [the term "device" DOES include in vitro diagnostic products used to aid in the diagnosis of disease or verification of pregnancy]

Under DSHEA, a ______ _______ is defined as a product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: - a vitamin - a mineral - an herb/botanical - an amino acid - a dietary substance for use by humans to supp. the diet by increasing the total dietary intake - a concrete, metabolite, constituent, extract, or combo

dietary supplement

Product labeling must include what?

either the supplier's domestic address or a continuously operating toll-free telephone number so customers can report serious AEs

In 2004 the FDA banned all __________ products.

ephedrine alkaloid dietary supps. (EDS)

How often must PDUFA be reauthorized?

every 5 years

Practice that involves the innovator company paying the generic manufacturer NOT to market its generic.

exclusion payments or pay-for-delay agreements

The Johnson decision prompted Congress to amend the Pure Food and Drug Act of 1906 in 1912 to prohibit what?

false and fraudulent efficacy claims

The purpose of _______ ________ is to clarify laws or regulations, to explain how compliance w/ the laws or regulations may be achieved and to outline review and enforcement approaches.

guidance documents

The law requires the listing of any active ingredients for both prescription and nonprescription drugs and the quantity of each. It also requires that most labels contain names of inactive ingredients in alphabetical order for both drug classes. Prior to the FDAMA, listing ______ ingredients was not required.

inactive

In 1941 the FDCA was amended to allow the FDA to require batch certification of the safety and efficacy of ______ to ensure uniform potency.

insulin [However in 1997, the Food and Drug Administration Modernization Act eliminated the batch certification requirement for insulin & antibiotics]

If the literature is deemed to accompany the product, it is ______.

labeling

Direct-to-consumer (DTC) means...

manufacturer to consumer

Who is responsible for notifying sellers of a product recall? Who is responsible for notifying customers of a product recall?

manufacturers sellers

Congress amended the FDCA in 1976 to provide for more extensive regulation and administrative authority regarding the safety and efficacy of what?

medical devices

The Pure Food and Drug Act of 1906 had not granted the FDA the authority to ban unsafe drugs, so the FDA had to remove sulfanilamide elixir on the basis of a technical ________ violation - that an elixir must contain alcohol, and the product did not.

misbranding

The FTC regulates __________ drug adverting under the Federal Trade Commission Act.

nonprescripton

Why does the FDA assign the NDC number?

only for identification purposes

A pamphlet that must accompany the drug product and contains the essential scientific and medical info needed for safe and effective use of the drug by health care professionals.

package insert

In order to ultimately obtain approval for an ANDA under the PTRA, the generic manufacturer must make a ______ ______.

patent certification

In 1945 the FDCA was amended to allow the FDA to require batch certification of the safety and efficacy of ________.

penicillin [However in 1997, the Food and Drug Administration Modernization Act eliminated the batch certification requirement for insulin & antibiotics]

The FDA regulates _________ drug advertising under the FDCA.

prescription

"Adequate information for use" is used for ________ drugs, whereas "adequate directions for use" is used for ________ drugs.

prescription drugs; OTC drugs

___________ ______ ads name the drug and the condition it treats and are subject to regulations. ________ ads give the drug's name, but not its uses, and are not subject to regulation. ________ ads are educational in nature and do not mention the name of the product, only the name of the company.

product claim ads reminder ads help-seeking ads

The _____ assigned to a drug determines how rapidly it will proceed through the NDA process.

rating

The FDA prefers to regulate by ____________ if at all possible. But, the agency also may pursue a less formal avenue by publishing ________ ______.

regulation guidance documents

"one having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred."

tamper-resistant package

Labeling regulations require that a package insert contain info about the use of the drug during pregnancy, unless...

the drug is NOT absorbed systemically and NOT known to harm the fetus

Patent extensions are available only if...

the patent has NOT expired.

What event caused Congress to enact the Kefauver-Harris Amendment to the FDCA?

the thalidomide disaster

OTC products are evaluated on the basis of _____ ______.

therapeutic claims

The crucial issue in the determination of whether a product is a drug centers on whether the supplier made a ___________ claim or a ____________ claim.

therapeutic/health structure/function

What is the purpose of phase 1?

to detect ADVERSE EFFECTS...not efficacy

What is the purpose of phase 2?

to determine EFFICACY of the drug & the dosages at which efficacy occurs [further safety testing is done as well].

What is the intent of the REMS program?

to manage known or potential serious risks of the product

What is the primary purpose of the approval process for an IND?

to protect the safety of the humans who will participate in the clinical trials

What was the primary purpose of the FDA Safety and Innovation Act of 2012 (FDASIA)?

to reauthorize PDUFA

Under DSHEA the FDA is stripped of premarket approval authority, therefore the agency must prove that a dietary supp. is ________ before it can remove it from the market.

unsafe

To ensure that health care professionals have the most up-to-date info., manufacturers must include a list of all substantive changes made within the past _______ in the package insert.

year