RAC Exam - EU MDD/AIMDD & MDR NEWEST ACTUAL EXAM
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) - ANSWER:
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) - 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) - ANSWER: 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) - ANSWER: C: Food and Drug Administration
Modernization Act
Both regulations and guidance documents have the force of law. 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. True or
False?(2:2) - 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) - ANSWER: 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) - 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) - 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) - 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) - 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) - 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) - ANSWER: D: 80% and 125%
What is the definition of a biologic?(3:3) - ANSWER: A substance derived from or
made with the aid of living organisms.
What are the major categories of ICH guidelines?(3:4) - 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) - 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) - ANSWER: C: Federal Register
What five types of application meetings are available to sponsors submitting medical
devices to CDRH?(4:2) - 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) -
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) - 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
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) - ANSWER:
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) - 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) - ANSWER: 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) - ANSWER: C: Food and Drug Administration
Modernization Act
Both regulations and guidance documents have the force of law. 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. True or
False?(2:2) - 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) - ANSWER: 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) - 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) - 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) - 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) - 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) - 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) - ANSWER: D: 80% and 125%
What is the definition of a biologic?(3:3) - ANSWER: A substance derived from or
made with the aid of living organisms.
What are the major categories of ICH guidelines?(3:4) - 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) - 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) - ANSWER: C: Federal Register
What five types of application meetings are available to sponsors submitting medical
devices to CDRH?(4:2) - 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) -
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) - 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
