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RAC Exam Practice 2024/2025 Questions and Answers 100% Correct
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RAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% CorrectRAC Exam Practice 2024/2025 Questions and Answers 100% Correct Which of the following was NOT a requirement of t...

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  • September 29, 2024
  • 35
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • rac exam practice questions and answers
  • rac exam practice answers
  • which of the following was not a requirement of th

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RAC Exam Practice 2024/2025

Questions and Answers 100%

Correct


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) - 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) - ANSWER-D: Kefauver-

Harris Amendments




What is the definition of a biologic?(3:3) - ANSWER-A substance derived from

or made with the aid of living organisms.

,What are the major categories of ICH guidelines?(3:4) - ANSWER-Quality

Safety Efficacy Multidisciplinary




What is the deadline for an initial IND Safety report of a fatal or life-

threatening serious adverse event?(3:5) - ANSWER-7 days




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) - 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 1922b) GMPs for

the 21st Century initiative c) Food and Drug Administration Modernization

Act d) Food and Drug Administration Amendments Act(1:4) - ANSWER-C:

Food and Drug Administration Modernization Act




Both regulations and guidance documents have the force of law. True or

False?(2:1) - 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) - 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) -

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) - 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) - 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) - 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) - 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)

- 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) - ANSWER-

D: 80% and 125%

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