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