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 - Political Science - 178 pages
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advisory committee meeting Agency agenda Amanda Pedersen analysis application asked asor audit auditors Barton believe Center for Devices Center for Drugs Chairman clinical investigators clinical trial concerns conduct consultant correct D-penicillamine DD SAN FRAN December DeCola Dermatology Dingell Director discussion disease drug application drug development Drug Evaluation Edelson effective Evaluation and Research FDA review FDA's Food and Drug FRAN CA 415 FRAN DD SAN Freundlich Harter involved issues January January 17 letter months nvs aa participation Peck Phase III study photopheresis Pilot Drug placebo protocol qeqq questions received record requested response rheumatoid arthritis rheumatologist Rook Rowland scheduled scientific skin severity score sponsor staff statement study design subcommittee submitted sxxao tacrine Therakos therapy tion told treatment University of Pennsylvania Weisman Wintroub Woodcock