law acts & amendments

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coal
ID:
248641
Filename:
law acts & amendments
Updated:
2013-11-23 12:47:01
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law acts amendments
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law acts & amendments
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  1. pure food & drug act of 1906
    • safety of food & drugs
    • prohibit adulteration/misbranding
  2. pure food & drug act 1912 amendment
    prohibit fraudulent efficacy claims
  3. FD&C act 1938
    • safety of food,drugs,& cosmetics
    • sulfanilamide incident
  4. FD&C 1941 amendment
    allow FDA to batch certify safety & efficacy of insulin
  5. FD&C amendment 1945
    allow FDA to batch certify safety & efficacy of PCN's
  6. durham-humphrey amendment 1951
    • OTC/RX - "legend"
    • allow verbal prescriptions
    • allow for refills
  7. food additives amendment 1958
    food additives must have pre-market approval for safety
  8. Delaney amendments
    outlawed carcinogens as food additives
  9. Kefauver-harris amendment 1962
    • drugs(between 1938 & 1962)┬ámust be safe & EFFECTIVE
    • change in Rx marketing from FTC to FDA
    • required informed consent for drug testing
    • established CGMP

    thalidomide
  10. medical device amendment of 1976
    • FDA authority to regulate devices (class 1-3)
    • procedures or recalls

    IUD
  11. orphan drug act of 1983
    tax incentives & exclusive marketing incentives
  12. PDUFA
    manufacturers to pay fees when submitting applications to FDA
  13. Dietary supplement health & education acto fo 1994 DSHEA
    defines dietary supplement and the FDA had to regulate as foods
  14. FDA modernization act of 1997
    • fast track drug approval
    • FDA authority over OTC
    • label for inactive ingredients
  15. FDAAA 2007
    • increase/expand use of fees
    • mandates drug labeling related to safety
    • requires REMS
    • allows FDA to mandate product recall
  16. Sherman antitrust act
    protects competition
  17. lantham trademark act
    allows anyone to sue for misleading advertising
  18. robinson patman act 1936
    unlawful for sellers to discriminate in price

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