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Elixir Sulfanilamide 107, 1906 Elixir Sulfanil-amide 11 Elixir Sul-fanilamide Massengill 1938 6 (Food,Drugs,and Cosmetic Act FDCA) FDA FDA FDA (New Drug Applic-ation NDA) NDA FDA NDA 60 FDA Sherley FDA (misbr-anded) FDA (sulfas) FDA. FDA 1906 Tugwell Rexford 1933 Tugwell Copeland FDA 1935 Massengil 1937 4/17

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ACS FDA FDA FDA OASIS OASIS FDA FDA FDA FDA (API) FDA FDA FDA. FDA FDA (Notice of Detention and Hearing) ( ) FDA FDA (drug registration) (product listing) FDA FDA (Notice ofrefusal of Admission) GMP FDA (Detention Without Physical Examination DWPE) GMP GMP. 60 1962 FDA 1961 Kefauver-Harris 1962 FDA 10/17

FDA 1962 1983 FDA 150 1983 35% 1984 FDA FDA 1984 (Drug Price Competition and Patent Term Restoration Act) Waxman-Hatch Act Orrin Hatch HenryW axman 505(j) 1984 5 FDA (NDA), (Bioequivelence) (Abbreviated New Drug Application ANDA) 180 30. Hatch-Waxman Act FDA 1989 FDA FDA FDA FDA (Vitarin) FDA FDA 38 11/17

FDA FDA 1989 1992 5 13 (Generic Drug Enforcement Act) FDA 306(d)(4) FDA FDA FDA FDA FDA FDA (Federal Register) FDA FDA FDA FDA (, ) FDA FDA FDA 1) 2) (Permissive Debarment) FDA 5 3) (mandatory debarment) (permissived ebarment) 10 4) FDA 5) FDA 6) FDA 90% 90% debarment. OTC 1906 (Pure Food and Drugs Act) 12/17

1938 (Food, Drug, and Cosmetic Act FDCA) FDA FDA (NDA) Grandfather 201(p) 1938 (NDA) FDA 1938 OTC FDA FDA OTC 1938 OTC OTC FDA OTC. OTC FDA FDA 1944 (OTC) FDA 1948 FDA (misbranded) FDA 20 40 FDA 1951 Durham-Humphrey (Prescription Drug Amendment) Durham-Humphrey 1938 (prescription drugs) (OTC) :(1) 502(d) (2) 13/17

(3) (NDA) Durham-Humphrey OTC OTC OTC FDA Durham-Humphrey (Caution Federal law prohibits dispensing without prescription 1998 Rx Durham-Humphrey FDA OTC FDA 701(a) 1962 Kefauver FDA 1951 Durham-Humphrey FDA 1961 (thalidomide) Kefauver FDA FDA 1938 1962 FDA 1966 (National Academy of Science) (National Research Council) FDA (Drug Efficacy Study Implementation DESI) DESI 1938 1962 DESI. ( ) FDA 1906 1938 FDA FDA 1941 403(j) (recommended daily allowance RDA) FDA FDA 60 70 FDA 1976 (Vitamins And Minerals Amendments) Proxmire FDA 14/17

Proxmire FDA (Food additives) 1958 (Food Additives Amendment) FDA FDA FDA FDA (1) (2) (3) (4) (5) FDA FDA FDA 1990 FDA FDA FDA FDA (Black Currant Oil) 1988 FDA (Black Currant Oil) Traco Traco Traco FDA (gelatin) (gelatin) FDA 1993 1 FDA (dietary supplement) FDA FDA. 1990 (Nutrition Labeling and Education Act NLEA) NLEA (herbs or similar nutri-tional substances) FDA 15/17

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