RAC Exam practice exam questions with answers

RAC Exam practice exam questions with
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answers

Which of the following was NOT a requirement of the original
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Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof
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of safety c) Authorized standards of identify d) Safe tolerances
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for unavoidable poisonous substances(1:1) - CORRECT ANSWERS
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✔✔A: Proof of efficacy|\ |\ |\




Which amendments to the FD&C Act resulted from the
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thalidomide tragedy? a) Durham-Humphrey Amendments b) |\ |\ |\ |\ |\ |\


Hatch-Waxman Act c) Controlled Substances Act d) Kefauver- |\ |\ |\ |\ |\ |\ |\


Harris Amendments (1:2) - CORRECT ANSWERS ✔✔D: Kefauver-
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Harris Amendments |\




The Color Additive Amendment of 1960 required FDA to prove
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that a color additive was unsafe before removing it from the
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market. a) True b) False(1:3) - CORRECT ANSWERS ✔✔B: False
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What has been described as "the most extensive change to the
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agency's practices since 1938?" a) Prescription Drug User Fee Act
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of 1922b) GMPs for the 21st Century initiative c) Food and Drug
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Administration Modernization Act d) Food and Drug |\ |\ |\ |\ |\ |\ |\


Administration Amendments Act(1:4) - CORRECT ANSWERS ✔✔C: |\ |\ |\ |\ |\ |\ |\


Food and Drug Administration Modernization Act
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,Both regulations and guidance documents have the force of law.
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True or False?(2:1) - CORRECT ANSWERS ✔✔False. Only
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regulations have the force of law. |\ |\ |\ |\ |\




Although FDA's statutory authority does not extend to the
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occupational safety and health responsibilities of OSHA the |\ |\ |\ |\ |\ |\ |\ |\


agencies coordinate their efforts in matters of related
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responsibility such as unshielded syringes and natural rubber |\ |\ |\ |\ |\ |\ |\ |\


latex. True or False?(2:2) - CORRECT ANSWERS ✔✔True
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An FDA petition much contain which of the following? a) Action
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requested b) Statement of grounds c) Environmental impact d)
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All of the above(2:3) - CORRECT ANSWERS ✔✔D: All of the above
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Drugs may be eligible for over-the-counter status when: a) They
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have been marketed to a material extent b) They have been
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marketed for a material time c) Are generally recognized as safe
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d) All of the above(2:4) - CORRECT ANSWERS ✔✔D: All of the
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above


Biologics are cleared for marketing through which process ?a)
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Establishment License Application (ELA)b) Product License |\ |\ |\ |\ |\ |\


Application (PLA)c) Biologics License Application (BLA)d) All of the
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above(2:5) - CORRECT ANSWERS ✔✔C: Biologics License
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Application (BLA) |\




A Special 510(k) relies on the following information: a) Design
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control documentation b) Guidance documents c) Consensus
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standards d) All of the above(2:6) - CORRECT ANSWERS ✔✔A:
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Design control documentation |\ |\

, Which act required rulemaking meetings to be open to the
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public? a) Moonshine Act b) Government in the Sunshine Act c)
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Food Drug and Cosmetics Act d) Administrative Amendments
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Act(2:7) - CORRECT ANSWERS ✔✔B: Government in the Sunshine
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Act
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Which of the following does not distinguish the development of
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drugs for animal use from those for human use: a) The ability to
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use known data from the development of a drug for use in
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humans or other animal species as applicable. b) Generally
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safety and efficacy studies require only 10s of animals per group
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compared to the 100s of patients per group required for human |\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\


drugs. c) Does not have user fees for NADAs. d) Species class
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and breed of animals as well as geographical differences are
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more relevant.(3:1) - CORRECT ANSWERS ✔✔C: Does not have
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user fees for NADAs.|\ |\ |\




A generic drug is deemed bioequivalent to the RLD if in clinical
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bioequivalence studies the 90% confidence intervals for the ratio |\ |\ |\ |\ |\ |\ |\ |\ |\


of population geometric means between the two treatments
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based on log-transformed data is contained within the
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equivalence limits of ____% - ____% for AUC and Cmax. a) 80 120 |\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\


b) 75 125 c) 90 110 d) 80 125(3:2) - CORRECT ANSWERS ✔✔D:
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80% and 125% |\ |\




What is the definition of a biologic?(3:3) - CORRECT ANSWERS
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✔✔A substance derived from or made with the aid of living
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organisms.