FDA's Drug and Device Review Process: Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, Second Session, February 6, 1992, Volume 4
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
U.S. Government Printing Office, 1992 - Drugs - 178 pages
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advisory committee meeting advisory panel Agency agenda Amanda Pedersen analysis application Aprqs asked audit auditors Barton believe Center for Devices Center for Drugs Chairman clinical investigators clinical trial conduct consultant correct D-penicillamine DD SAN FRAN December DeCola Dermatology Dingell Director discussion disease Drug Administration drug application drug approval drug development Drug Evaluation Edelson effective Evaluation and Research FDA review FDA's Food and Drug Freundlich going Harter issues January January 17 letter months participate patients Peck Phase III study photopheresis placebo problems questions received record requested response rheumatologist Rook Rowland scheduled scientific skin severity score sllao sponsor staff statement study design subcommittee submitted systemic sclerosis tacrine teth Therakos therapy tion told treatment University of Pennsylvania weaa Weisman Wintroub Woodcock Yale-New Haven Hospital