RAC Complete Sample Practice Final Exam 2024.
Side A - CORRECT ANSWER Side B
Which of the following was NOT a requirement of the original Food, Drug, and Cosmetic Act of 1938?
a) Proof of efficacy
b) Proof of safety
c) Authorized standards of identify
d) Safe tolerances for unavoidable po...
RAC Complete Sample Practice Exam 2024.
Side A - CORRECT ANSWER Side B
Which of the following was NOT a requirement of the original Food, Drug, and Cosmetic Act of 1938?
a) Proof of efficacy
b) Proof of safety
c) Authorized standards of identify
d) Safe tolerances for unavoidable poisonous substances(1:1) - CORRECT ANSWER A: Proof of efficacy
Which amendments to the FD&C Act resulted from the thalidomide tragedy?
a) Durham-Humphrey Amendments
b) Hatch-Waxman Act
c) Controlled Substances Act
d) Kefauver-Harris Amendments(1:2) - CORRECT ANSWER D: Kefauver-Harris Amendments
The Color Additive Amendment of 1960 required FDA to prove that a color additive was unsafe before removing it from the market.
a) True
b) False(1:3) - CORRECT ANSWER B: False
What has been described as "the most extensive change to the agency's practices since 1938?" a) Prescription Drug User Fee Act of 1922
b) GMPs for the 21st Century initiative
c) Food and Drug Administration Modernization Act d) Food and Drug Administration Amendments Act(1:4) - CORRECT ANSWER C: Food and Drug Administration Modernization Act
Both regulations and guidance documents have the force of law. True or False?(2:1) - CORRECT ANSWER False. Only regulations have the force of law.
Although FDA's statutory authority does not extend to the occupational safety and health responsibilities of OSHA, the agencies coordinate their efforts in matters of related responsibility such as
unshielded syringes and natural rubber latex. True or False?(2:2) - CORRECT ANSWER True
An FDA petition much contain which of the following?
a) Action requested
b) Statement of grounds
c) Environmental impact
d) All of the above(2:3) - CORRECT ANSWER D: All of the above
Drugs may be eligible for over-the-counter status when:
a) They have been marketed to a material extent
b) They have been marketed for a material time
c) Are generally recognized as safe
d) All of the above(2:4) - CORRECT ANSWER D: All of the above
Biologics are cleared for marketing through which process?a) Establishment License Application (ELA)
b) Product License Application (PLA)
c) Biologics License Application (BLA)
d) All of the above(2:5) - CORRECT ANSWER C: Biologics License Application (BLA) A Special 510(k) relies on the following information:
a) Design control documentation
b) Guidance documents
c) Consensus standards
d) All of the above(2:6) - CORRECT ANSWER A: Design control documentation
Which act required rulemaking meetings to be open to the public?
a) Moonshine Act
b) Government in the Sunshine Act
c) Food, Drug and Cosmetics Act
d) Administrative Amendments Act(2:7) - CORRECT ANSWER B: Government in the Sunshine Act
Which of the following does not distinguish the development of drugs for animal use from those for human use:
a) The ability to use known data from the development of a drug for use in humans or other animal species as applicable.
b) Generally, safety and efficacy studies require only 10s of animals per group compared to the 100s of patients per group required for human drugs.
c) Does not have user fees for NADAs.
d) Species, class, and breed of animals as well as geographical differences are more relevant.(3:1) - CORRECT ANSWER C: Does not have user fees for NADAs.
A generic drug is deemed bioequivalent to the RLD if in clinical bioequivalence studies the 90% confidence intervals for the ratio of population geometric means between the two treatments, based on
log-transformed data, is contained within the equivalence limits of ____% - ____% for AUC and Cmax.
a) 80, 120
b) 75,125
c) 90.110
d) 80,125(3:2) - CORRECT ANSWER D: 80% and 125%
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