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9 Cards in this Set

  • Front
  • Back
1906 Pure Food and Drug Act
Prohibited the interstate commerce of adultered (not pure) food and drugs
1911 Shirley Amendments
Prohibited false and misleading claims for drug products
1938 Federal Food, Drug, and Cosmetic Act
Scientific proof of safety before a drug could be marketed (sulfonilamide disaster)
1951 Durham-Hunphrey Amendment
Created two classes of products prescription and OTC; created "legend drugs"
1962 Harris-Kefauver Amendments
Scientific proof of efficacy (effectiveness)

DESI drugs - drugs marketed between 1938 - 1962 were studied to determine their effectiveness (about 3000) and were classified as either effective, probably effective, possibly effective, or in effective
1983 Orphan Drug Act
Gave economic and tax incentives for pharmaceutical manufacturers to develop drugs for rare disease such as:
1) diseases which effect less than 200,000 patients in the US
2) diseases with more than 200,000 patients in which the cost of development will never be recouped
1984 Drug Price Competition and Patent Restoration Act
Created the ANDA for generic drugs (prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting approval

Orange Book: shows bioequivalence for generics (AA and AB are equivalent, but anything starting with a "B" is not equivalent)
Prescription Drug Marketing Act of 1984
This act
1) regulated samples
2) banned re-importing drugs from other countries
3) regulated who hospitals can sell to
1994 Dietary Supplement Health and Education Act
Made herbals officially dietary supplements and mandated they contain the disclaimer, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."