Evolution of the Food and Drug Administration Review Questions and Answers Already Passed
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Course
Food and Drug Administration
Institution
Food And Drug Administration
Evolution of the Food and Drug Administration Review Questions and Answers Already Passed
FDCA - Answers The Food, Drug, and Cosmetic Act, a law enacted in 1938 to require proof of safety for drug products not already on the market.
Durham-Humphrey Amendment - Answers Legislation that establishe...
Evolution of the Food and Drug Administration Review Questions and Answers Already Passed
FDCA - Answers The Food, Drug, and Cosmetic Act, a law enacted in 1938 to require proof of safety for
drug products not already on the market.
Durham-Humphrey Amendment - Answers Legislation that established two classes of drugs: OTC and Rx.
Kefauver-Harris Amendment - Answers 1962 legislation adding the efficacy requirement for drug
products, made retroactive to 1938, exempting drugs marketed prior to 1938.
Orphan Drug Act of 1983 - Answers Legislation providing incentives for the development and marketing
of drugs for rare conditions or diseases.
DPC/PTRA of 1984 - Answers Legislation facilitating generic drug approval and affording patent
extensions to innovator drug products.
PDMA of 1987 - Answers Legislation establishing requirements for prescription drug sample
distributions and prohibiting the resale of pharmaceuticals.
PDUFA of 1992 - Answers Legislation requiring manufacturers to pay application fees for NDAs.
DSHEA of 1994 - Answers Legislation creating a class of products known as dietary supplements and
requiring the FDA to regulate them more as food than drugs.
FDAMA of 1997 - Answers Legislation streamlining regulatory procedures to expedite drug and device
availability and creating a fast track process for serious or life-threatening diseases.
FDAAA of 2007 - Answers Legislation providing enhanced authority to regulate drug safety, including the
REMS program for necessary drugs.
FDASIA of 2012 - Answers Legislation adding user fees for generic drugs and biosimilars.
DSQA of 2013 - Answers Legislation clarifying pharmacy compounding law and establishing track and
trace requirements for prescription drugs.
Cures Act of 2016 - Answers Legislation streamlining drug development and approval processes and
allowing for more patient experience data.
FDA - Answers The Food and Drug Administration, vested with the FDCA, accountable to the DHHS, and
comprising 5 offices under the Office of the Commissioner.
CDER - Answers A component of the FDA's Office of Medical Products and Tobacco, responsible for
drugs, biologics, and devices impacting pharmacy practice.
Drug (under FDCA) - Answers Includes any articles intended for use in disease or to affect the structure
or function of the body.
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