The Adequacy of FDA to Assure the Safety of the Nation's Drug Supply: Hearing Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, First Session, February 13, March 22, 2007, Volume 4
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
U.S. Government Printing Office, Jan 1, 2007 - Drugs - 317 pages
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adverse events Advisory Committee meeting agency AIDAC meeting Andrew von Eschenbach antibiotics approved Ketek asked Aventis Bextra black box warning BURGESS CDER Chairman Chuck Grassley CISNEROS clinical trials Commissioner concerns conduct Congress criminal investigation data integrity decision-making decisions DEGETTE documents Drug Administration drug application drug approval drug sponsors e-mail effective enrolled ESCHENBACH evaluation FDA employees FDA managers FDA needs FDA officials FDA's February 13 Food and Drug fraud FURBERG going GRAHAM hearing Kirkman-Campbell label liver failure look Medicine muraglitazar Nissen Office opening statement Oversight and Investigations panel patients PDUFA placebo pneumonia post-marketing postmarket drug safety postmarket safety PSATY public health questions recommended regulatory response Review Division risk Ross safety data safety study Sanofi-Aventis scientific Senator GRASSLEY serious staff STUPAK subcommittee submitted telithromycin testimony Thank Vioxx WALDEN whistleblowers WHITFIELD WOOSLEY