RAC COMPREHENSIVE SCRIPT 2026
QUESTIONS AND SOLUTIONS
◉ 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
◉ 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 1922
b) 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
QUESTIONS AND SOLUTIONS
◉ 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
◉ 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 1922
b) 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
