6. To enforce the Food Drug and Cosmetic Act FDA relies on prohibiting two “viol
ID: 60400 • Letter: 6
Question
6. To enforce the Food Drug and Cosmetic Act FDA relies on prohibiting two “violative acts” that have been part of the law since 1906: __________ and ___________.
7. The Food, Drug and Cosmetic Act
a. Is about the regulation of physical “things” most of which are put into, or onto, or used with the bodies of humans and animals.
b. Has not fundamentally changed since 1938
c. Has always allowed FDA to grant exclusivity for newly approved drugs
d. Has sole authority over product advertising
e. None of the above
8. Phase 1 trials
a. Are only started when all the animal testing, including carcinogenicity and reproductive toxicity has been completed
b. Are not ethical to conduct in healthy volunteers but should always be done patients who might benefit from the drug
c. Usually involve several hundred participants
d. Determine how the drug is absorbed and metabolized and provide the initial evidence to select a dose or range of doses for later trials.
e. None of the above
9. The Government Accountability Office report on compounding observed the following
a. The compounding provisions in the Food Drug and Cosmetic Act have been unchanged since 1938
b. Compounding pharmacies have not challenged FDA’s authority to regulate and inspect them
c. Court decisions have resulted in different provisions of the law in effect in different States
d. The distinction between large volume compounding and drug manufacturing is clearly defined and agreed upon
e. The GAO concluded there was little role for FDA given that the States regulate the practice of pharmacy.
10. Which of the following is not usually considered a controlled trial? (As in FDA’s definition of an “adequate and well controlled trial”?)
a. Comparison of drug treated group to a similar group not treated with that drug in the medical literature
b. Comparison of one group taking a high dose to another group taking a low dose of the same drug
c. Reports of individual patients treated with a new drug
d. Comparison of a drug treated group to another group not treated at all
e. Most phase 3 “pivotal trials” upon which provide efficacy evidence
11. The Shirley Amendments to the Pure Food and Drug Act:
a. Created a new standard for Drug claims: False and fraudulent
b. Dealt largely with the requirements for manufacturing standards
c. Provided FDA with the authority to conduct inspections
d. Is still the standard today: FDA must determine that a claim is fraudulent to not allow that claim
e. Were the first good manufacturing requirements in the law.
12. Which of the following is false:
a. Compounding is regulated by the States
b. Compounding is regulated by the FDA
c. Compounding is legal as long as it does not involve interstate commerce
d. In some instances, compounding has been encouraged by FDA to address drug shortages
13. Once selected for as a candidate for human testing, most new drug candidates fail and are abandoned:
a. During phase 1 or 2
b. During phase 3
c. After a drug is marketed
d. Before the new drug is even tested in humans
14. With respect to mandatory vaccination to attend school
a. California’s governor has recently vetoed a law requiring vaccination to attend school
b. School vaccination laws are in force in California for home schooled children
c. The courts have consistently found the that the 1st Amendment protects the right of parents to refuse vaccination before entry to school
d. Diphtheria is an example of an infection that was not completely controlled until there was mandatory vaccination
e. Such laws are not necessary because voluntary vaccination is adequate to provide “herd immunity.”
15. The 1962 KefauverHarris Act amended the Food Drug and Cosmetic Act did not require
a. Evaluation of effectiveness of all drugs on the market since 1938
b. Stricter controls over investigational new drugs
c. Regulation of Biologic products, such as vaccines, by the FDA for the first time
d. Requirements for good manufacturing procedures
16. The approval of a New Drug Application requires
a. That FDA hold a public advisory committee hearing
b. That with respect to effectiveness, substantial evidence requires that the sponsor conduct adequate tests by all methods reasonably applicable to show whether a drug is effective for the indicated conditions
c. That the review decision is made by external scientists who are scientifically qualified to determine if the product is safe and effective for the intended use.
d. That all studies in the application meet the standard of adequate and well controlled.
e. That FDA either approve the application or provide a “complete response” that identifies the deficiencies that must be addressed before approval.
17. The US Pharmacopeia
a. Was created in 1906 as part of the efforts to define a drug in the Pure Food and Drug Act.
b. Had an important role for pharmacists compounding drugs, particularly before the manufacture of modern medications.
c. Has a Homeopathic Pharmacopeia counterpart that also is part of the definition of a drug in the Food Drug and Cosmetic Act.
d. Is a part of the FDA.
e. Emphasizes product effectiveness rather than product quality
18. To FDA a “new drug” is
a. Any chemical not previously used for the prevention, treatment, mitigation or diagnosis of disease or to alter body structure and function (other than food.)
b. A new dosage form of an approved drug
c. A combination of two approved drugs d. A new use for an approved drug
e. All of the above
19. Which of the following statements about reproductive toxicology (animal) studies is true
a. When there are no signs of reproductive effects in animals it is safe to use those drugs in humans
b. Reproductive toxicology studies include developmental studies of young animals exposed to the drug while still fetuses
c. One of the most important type of reproductive studies is exposure of unborn animals during the period of organ and limb formation, early in pregnancy
d. All of the above
e. bandc
20. The HatchWaxman Amendments to the FDCA
a. Provide restoration of lost patent time up to five years any time FDA approves an NDA
b. Only provides generic drug exclusivity when a generic drug challenges an innovator’s patent
c. Applies to biologics and medical devices
d. Had little effect on the generic drug industry, although it modernized the approval process
e. All of the above
21. The changes to the Food Drug and Cosmetic Act in 1962 (the Kefauver – Harris Amendments)
a. Were the result of congressional investigation of the 400 deaths from chloramphenicol
b. Created new protections that required testing of new drugs for safety before approval
c. Required FDA approval before the investigational use of any new drug in human experiments
d. Required, for the first time, that labeling not be “false or misleading”
e. Removed the responsibility for advertising for overthecounter drugs from the Federal Trade Commission (FTC)
22. With respect to INDs
a. When a new protocol is submitted to an existing IND the sponsor must wait 30 days before proceeding.
b. An IND can be put on hold when it does not include pregnant women in the IND program.
c. A phase 1 study can be put on hold, although safe, if “The plan or protocol for the investigation is clearly deficient in design to meet its stated objectives.”
d. An IND is not required for pharmacokinetic studies for the purpose of generic drug approval e. All of the above
23. The Kefauver Amendments of 1962 to the Food Drug and Cosmetic Act added requirements except:
a. All drugs must be safe and effective, including all drugs approved by FDA since 1938
b. Drug manufacturers must collect safety information once a product is approved
c. New drug approvals were for a five year period and had to be renewed every five years to remain on the market.
d. New drugs require FDA consent when they are studied before approval during what would be known as the IND phases
24. Which of the following is true:
a. As an agency created under administrative law, FDA can make changes to the Food Drug and Cosmetic Act through rule making.
b. The relevant regulations for FDA are not just found in 21 CFR but also 45 CFR
c. Guidances explain the law and regulations and the “advice” they provide is as binding as a regulation.
d. Regulations do not have the same enforceability as Statues, they are only one way to comply with the law.
e. New guidances must go through the same noticeandcomment rulemaking required of new regulations
25. The Commissioner of the FDA:
a. Must be a physician or veterinarian;
b. Is a political appointee who in recent years requires confirmation by the House of Representatives
c. Has an Office of Combination Products as part of the Commissioner’s Office
d. Hires the FDA Chief Counsel who reports to the Commissioner
e. All of the above
Explanation / Answer
7) Has always allowed FDA to grant exclusivity for newly approved drugs
8) Determine how the drug is absorbed and metabolized and provide the initial evidence to select a dose or range of doses for later trials.
9) Court decisions have resulted in different provisions of the law in effect in different States
10) Comparison of drug treated group to a similar group not treated with that drug in the medical literature
11) Is still the standard today: FDA must determine that a claim is fraudulent to not allow that claim
12) Compounding is regulated by the States
13) During phase 1 or 2
14) Diphtheria is an example of an infection that was not completely controlled until there was mandatory vaccination
15) Evaluation of effectiveness of all drugs on the market since 1938
16) That FDA either approve the application or provide a “complete response” that identifies the deficiencies that must be addressed before approval.
17) Is a part of the FDA.
18) A new dosage form of an approved drug
19) All of the above
20) Provide restoration of lost patent time up to five years any time FDA approves an NDA
21) Required FDA approval before the investigational use of any new drug in human experiments
22) A phase 1 study can be put on hold, although safe, if “The plan or protocol for the investigation is clearly deficient in design to meet its stated objectives.”
23) All drugs must be safe and effective, including all drugs approved by FDA since 1938
24) Guidances explain the law and regulations and the “advice” they provide is as binding as a regulation.
25) All of the above
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