Evolution_Of_The_Food_And_Drug_Administration_Study_Guide_Comprehensive.pdf

EVOLUTION OF THE FOOD
COMPREHENSIVE REVIEW WITH
VERIFIED SOLUTIONS



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


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


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


◉DPC/PTRA of 1984 . Answer: Legislation facilitating generic drug
approval and affording patent extensions to innovator drug products.


◉PDMA of 1987 . Answer: Legislation establishing requirements for
prescription drug sample distributions and prohibiting the resale of
pharmaceuticals.

, ◉PDUFA of 1992 . Answer: Legislation requiring manufacturers to pay
application fees for NDAs.


◉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.


◉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.


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


◉FDASIA of 2012 . Answer: Legislation adding user fees for generic
drugs and biosimilars.


◉DSQA of 2013 . Answer: Legislation clarifying pharmacy
compounding law and establishing track and trace requirements for
prescription drugs.