Evolution of the Food and Drug Administration Exam Questions and Answers 100% Pass

Evolution of the Food and Drug
Administration Exam Questions and
Answers 100% Pass

FDCA - ANSWER-The Food, Drug, and Cosmetic Act, a law enacted in 1938 to
require proof of safety for drug products not already on the market.



Question: Durham-Humphrey Amendment - ANSWER-Legislation that
established two classes of drugs: OTC and Rx.



Question: Kefauver-Harris Amendment - ANSWER-1962 legislation adding the
efficacy requirement for drug products, made retroactive to 1938, exempting drugs
marketed prior to 1938.



Question: Orphan Drug Act of 1983 - ANSWER-Legislation providing incentives
for the development and marketing of drugs for rare conditions or diseases.



Question: DPC/PTRA of 1984 - ANSWER-Legislation facilitating generic drug
approval and affording patent extensions to innovator drug products.

, Question: PDMA of 1987 - ANSWER-Legislation establishing requirements for
prescription drug sample distributions and prohibiting the resale of
pharmaceuticals.



Question: PDUFA of 1992 - ANSWER-Legislation requiring manufacturers to pay
application fees for NDAs.



Question: DSHEA of 1994 - ANSWER-Legislation creating a class of products
known as dietary supplements and requiring the FDA to regulate them more as
food than drugs.



Question: FDAMA of 1997 - ANSWER-Legislation streamlining regulatory
procedures to expedite drug and device availability and creating a fast track process
for serious or life-threatening diseases.



Question: FDAAA of 2007 - ANSWER-Legislation providing enhanced authority
to regulate drug safety, including the REMS program for necessary drugs.



Question: FDASIA of 2012 - ANSWER-Legislation adding user fees for generic
drugs and biosimilars.



Question: DSQA of 2013 - ANSWER-Legislation clarifying pharmacy
compounding law and establishing track and trace requirements for prescription
drugs.