Answer Unavoidable Contaminants in Food for Human Consumption by FDA Flashcards

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)

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)

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)

What has been described as "the most extensive change to the agency's practices since 1938?"
a) Prescription Drug User Fee Act of 1922
b) GMPs for the 21st Century initiative
c) Food and Drug Administration Modernization Act
d) Food and Drug Administration Amendments Act
(1:4)

Both regulations and guidance documents have the force of law. True or False?

(2:1)

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)

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)

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)

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)

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)

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)

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)

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)

What is the definition of a biologic?
(3:3)

What are the major categories of ICH guidelines?
(3:4)