RAC sample Exam Questions and Answers with Verified Solutions |
Latest 2026 Update
Q: Side A
Answer:
Side B
Q: Which of the following was NOT a requirement of the original Food, Drug,
and Cosmetic Act of 1938?
Proof of efficacy
Proof of safety
Authorized standards of identify
Safe tolerances for unavoidable poisonous substances(1:1)
Answer:
A: Proof of efficacy
Q: Which amendments to the FD&C Act resulted from the thalidomide tragedy?
Durham-Humphrey Amendments
Hatch-Waxman Act
Controlled Substances Act
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.
True
Q: False(1:3)
Answer:
B: False
What has been described as "the most extensive change to the agency's practices
since 1938?"
Prescription Drug User Fee Act of 1922
GMPs for the 21st Century initiative
Food and Drug Administration Modernization Act
,Q: 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.
Q: 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.
Q: True or False?(2:2)
Answer:
True
Q: An FDA petition much contain which of the following?
Action requested
Statement of grounds
Environmental impact
All of the above(2:3)
Answer:
D: All of the above
Drugs may be eligible for over-the-counter status when:
They have been marketed to a material extent
They have been marketed for a material time
Are generally recognized as safe
Q: 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)
Product License Application (PLA)
Biologics License Application (BLA)
, Q: All of the above(2:5)
Answer:
C: Biologics License Application (BLA)
A Special 510(k) relies on the following information:
Design control documentation
Guidance documents
Consensus standards
Q: All of the above(2:6)
Answer:
A: Design control documentation
Q: Which act required rulemaking meetings to be open to the public?
Moonshine Act
Government in the Sunshine Act
Food, Drug and Cosmetics Act
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:
The ability to use known data from the development of a drug for use in humans or
other animal species as applicable.
Generally, safety and efficacy studies require only 10s of animals per group
compared to the 100s of patients per group required for human drugs.
Does not have user fees for NADAs.
Species, class, and breed of animals as well as geographical differences are more
relevant.(3:1) -
C: Does not have user fees for NADAs.
Q: 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 %
Latest 2026 Update
Q: Side A
Answer:
Side B
Q: Which of the following was NOT a requirement of the original Food, Drug,
and Cosmetic Act of 1938?
Proof of efficacy
Proof of safety
Authorized standards of identify
Safe tolerances for unavoidable poisonous substances(1:1)
Answer:
A: Proof of efficacy
Q: Which amendments to the FD&C Act resulted from the thalidomide tragedy?
Durham-Humphrey Amendments
Hatch-Waxman Act
Controlled Substances Act
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.
True
Q: False(1:3)
Answer:
B: False
What has been described as "the most extensive change to the agency's practices
since 1938?"
Prescription Drug User Fee Act of 1922
GMPs for the 21st Century initiative
Food and Drug Administration Modernization Act
,Q: 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.
Q: 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.
Q: True or False?(2:2)
Answer:
True
Q: An FDA petition much contain which of the following?
Action requested
Statement of grounds
Environmental impact
All of the above(2:3)
Answer:
D: All of the above
Drugs may be eligible for over-the-counter status when:
They have been marketed to a material extent
They have been marketed for a material time
Are generally recognized as safe
Q: 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)
Product License Application (PLA)
Biologics License Application (BLA)
, Q: All of the above(2:5)
Answer:
C: Biologics License Application (BLA)
A Special 510(k) relies on the following information:
Design control documentation
Guidance documents
Consensus standards
Q: All of the above(2:6)
Answer:
A: Design control documentation
Q: Which act required rulemaking meetings to be open to the public?
Moonshine Act
Government in the Sunshine Act
Food, Drug and Cosmetics Act
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:
The ability to use known data from the development of a drug for use in humans or
other animal species as applicable.
Generally, safety and efficacy studies require only 10s of animals per group
compared to the 100s of patients per group required for human drugs.
Does not have user fees for NADAs.
Species, class, and breed of animals as well as geographical differences are more
relevant.(3:1) -
C: Does not have user fees for NADAs.
Q: 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 %
