prohibited adulteration and misbranding of foods and drugs
didn't prevent false or misleading efficacy claims
food, drug, and cosmetic act of 1938
prompted by sulfanilamide elixir tragedy
drugs can't be marketed until proven safe for use
expanded definitions of misbranding and adulteration
directions for use
warnings about habit forming properties of certain drugs
exempted drugs marketed before 1938
durham-humphrey amendment of 1951
established Rx and OTC drugs
authorized oral rx's and refills
Rx doesn't have have to have adequate directions for use, if they have the legend
Kefauver-harris amendment of 1962
prompted by thalidomide tragedy
safe and effective
ftc to fda
GMPs
informed consent of research subjects
reporting of AEs
orphan drug act of 1938
gave tax and exclusive licensing incentives for manufactueres that develop and market drugs for treatment of rare diseases and conditions ( < 200,000 ppl)
Waxman-Hatch amendment
streamlined generic drug approval process
gave patent extensions to innovator drugs
prescription drug marketing act of 1987
established sales restrictions and record keeping requirements for rx drug samples
prohibited hospitals from reselling pharmaceutical purchases to other businesses
state licensing of drug wholesalers
prescription drug user fee act of 1992
required manufacturers seeking NDAs to pay fees for applications and supplements when the FDA has to review clinical studies
dietary supplement health and education actu of 1994
defined dietary supplements
permited manufactureres to make claims tht would have been illegal under the FDCA
dietary supplements more foods than drugs
food and drug administration modernization act of 1997
made a more timely review of applications
created fast track approval process for drugs for serious or life threatening diseases
expanded FDA authority over OTCs
Food and drug administration amendments act of 2007