FDA Reform Legislation: Hearings Before the Subcommittee on Health and Environment of the Committee on Commerce, House of Representatives, One Hundred Fourth Congress, Second Session, on H.R. 3199, 3200, and 3201, May 1 and 2, 1996, Volume 4
U.S. Government Printing Office, 1996 - Drugs - 458 pages
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accredited agency agency's Amendment American animal drugs approval process approved drugs benefit Bilbray Bilirakis bill bioequivalence Bliley blood Burr cancer carcinogens Center Chairman changes clinical trials committee companies Congress consumers cosmetic decision Delaney Clause diseases drug applications drug approval drug approval process drug development evaluation FDA reform FDA regulation FDA review FDA's Federal food additive Food and Drug gene therapy Greenwood health claims important improve industry inspections investigation issue Kessler labeling legislation life-threatening manufacturers medical devices medicine off-label Orphan Drug OTC drugs panel patients pharmaceutical physicians Prepared Statement prescription drugs problems protect public health question regulatory requirements response risk safe and effective safety and efficacy scientific Secretary sponsor standards studies submitted testimony testing Thank therapies third party review tion treatment user fees Waxman