RAC EXAM PRACTICE QUESTIONS &
VERIFIED ANSWERS RATED 100%
CORRECT
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
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
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
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
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
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 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
What is the deadline for an initial IND Safety report of a fatal or life-threatening serious adverse
event?(3:5) - correct answer ✔✔7 days
FDA promulgates regulations in which of the following? a) Code of Federal Regulations b)
Docket Management System c) Federal Register d) Federal Docket(4:1) - correct answer ✔✔C:
Federal Register
What five types of application meetings are available to sponsors submitting medical devices to
CDRH?(4:2) - correct answer ✔✔Agreement Determination Pre-IDE Pre-PMA and PMA day-100
Under what circumstances is it appropriate to request a Type A meeting?(4:3) - correct answer
✔✔The Type A meeting is one that is immediately necessary for an otherwise stalled drug
development program to proceed. Type A meetings are reserved for dispute resolution
discussion of clinical holds and special protocol assessment meetings.
True or False: A hearing to review the safety and efficacy of an NDC is a public hearing before
the commissioner. (4:4) - correct answer ✔✔False. A hearing to review the safety and efficacy of
an NDA is a public hearing before a public advisory committee.
True or False: FDA advisory committee meetings may be completely closed to the public and
notice of a meeting is not required to be published until the day of the meeting. (5:1) - correct
answer ✔✔False: Advisory committee meetings may be closed but no advisory committee
meeting can be completely closed (21 CFR 14.27)
VERIFIED ANSWERS RATED 100%
CORRECT
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
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
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
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
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
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 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
What is the deadline for an initial IND Safety report of a fatal or life-threatening serious adverse
event?(3:5) - correct answer ✔✔7 days
FDA promulgates regulations in which of the following? a) Code of Federal Regulations b)
Docket Management System c) Federal Register d) Federal Docket(4:1) - correct answer ✔✔C:
Federal Register
What five types of application meetings are available to sponsors submitting medical devices to
CDRH?(4:2) - correct answer ✔✔Agreement Determination Pre-IDE Pre-PMA and PMA day-100
Under what circumstances is it appropriate to request a Type A meeting?(4:3) - correct answer
✔✔The Type A meeting is one that is immediately necessary for an otherwise stalled drug
development program to proceed. Type A meetings are reserved for dispute resolution
discussion of clinical holds and special protocol assessment meetings.
True or False: A hearing to review the safety and efficacy of an NDC is a public hearing before
the commissioner. (4:4) - correct answer ✔✔False. A hearing to review the safety and efficacy of
an NDA is a public hearing before a public advisory committee.
True or False: FDA advisory committee meetings may be completely closed to the public and
notice of a meeting is not required to be published until the day of the meeting. (5:1) - correct
answer ✔✔False: Advisory committee meetings may be closed but no advisory committee
meeting can be completely closed (21 CFR 14.27)
