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RAC Exam practice/128 Questions And Answers (A+)
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RAC Exam practice/128 Questions And Answers (A+)Quiz :Which of the following was NOT a requirement of
the original Food Drug and Cosmetic Act of 1938? a) Proof
of effi cacy b) Proof of safety c) Authorized standards of
identify d) Safe tolerances for unavoidable poisonous
substances(1:1) -√Answer : A: Proof of effi cacy
Quiz :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
Quiz :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
Quiz :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) -√Answer : C: Food and Drug
Administration Modernization Act
Quiz :Both regulations and guidance documents have the
force of law. True or False?(2:1) -√Answer : False. Only
regulations have the force of law.
Quiz :Although FDA's statutory authority does not extend
to the occupational safety and health responsibilities of
OSHA the agencies coordinate their eff orts in matters of
,related responsibility such as unshielded syringes and
natural rubber latex. True or False?(2:2) -√Answer : True
Quiz :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
Quiz :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
Quiz :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)
Quiz :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
Quiz :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
Quiz :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 effi cacy
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
diff erences are more relevant.(3:1) -√Answer : C: Does
not have user fees for NADAs.
Quiz :A generic drug is deemed bioequivalent to the RLD
if in clinical bioequivalence studies the 90% confi dence
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) -√Answer : D: 80% and 125%
Quiz :What is the defi nition of a biologic?(3:3) -√Answer :
A substance derived from or made with the aid of living
organisms.
Quiz :What are the major categories of ICH guidelines?
(3:4) -√Answer : Quality Safety Effi cacy Multidisciplinary
Quiz :What is the deadline for an initial IND Safety report
of a fatal or life-threatening serious adverse event?(3:5) -
√Answer : 7 days
Quiz :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) -√Answer : C: Federal Register
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