RAC EXAM PRACTICE EXAM QUESTIONS WITH ANSWERS
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) - --Answers----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) - --Answers----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) - --Answers----D: 80% and 125%
,What is the definition of a biologic?(3:3) - --Answers----A
substance derived from or made with the aid of living organisms.
What are the major categories of ICH guidelines?(3:4) - --
Answers----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) - --Answers----7
days
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) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----C: Food
and Drug Administration Modernization Act
Both regulations and guidance documents have the force of law.
True or False?(2:1) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----A: Design
control documentation
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) - --Answers----C: Federal
Register
What five types of application meetings are available to sponsors
submitting medical devices to CDRH?(4:2) - --Answers----
Agreement Determination Pre-IDE Pre-PMA and PMA day-100
Under what circumstances is it appropriate to request a Type A
meeting?(4:3) - --Answers----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) - --
Answers----False. A hearing to review the safety and efficacy of
an NDA is a public hearing before a public advisory committee.
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) - --Answers----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) - --Answers----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) - --Answers----D: 80% and 125%
,What is the definition of a biologic?(3:3) - --Answers----A
substance derived from or made with the aid of living organisms.
What are the major categories of ICH guidelines?(3:4) - --
Answers----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) - --Answers----7
days
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) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----C: Food
and Drug Administration Modernization Act
Both regulations and guidance documents have the force of law.
True or False?(2:1) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----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) - --Answers----A: Design
control documentation
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) - --Answers----C: Federal
Register
What five types of application meetings are available to sponsors
submitting medical devices to CDRH?(4:2) - --Answers----
Agreement Determination Pre-IDE Pre-PMA and PMA day-100
Under what circumstances is it appropriate to request a Type A
meeting?(4:3) - --Answers----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) - --
Answers----False. A hearing to review the safety and efficacy of
an NDA is a public hearing before a public advisory committee.
