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RAC Exam practice Questions And Answers (Latest Update 2025)
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RAC Exam practice Questions And Answers (Latest Update 2025)
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RAC Exam practice Questions AndAnswers (Latest Update 2025)
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 1922b) 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
,RAC Exam practice Questions And
Answers (Latest Update 2025)
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
,RAC Exam practice Questions And
Answers (Latest Update 2025)
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
, RAC Exam practice Questions And
Answers (Latest Update 2025)
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%
What is the definition of a biologic?(3:3) - Correct Answer
✅ A substance derived from or made with the aid of living
organisms.
What are the major categories of ICH guidelines?(3:4) -
Correct Answer ✅ Quality Safety Efficacy Multidisciplinary
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