FDA Oversight: Blood Safety and the Implications of Pool Sizes in the Manufacture of Plasma Derivatives : Hearing Before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, First Session, July 31, 1997
U.S. Government Printing Office, Jan 1, 1998 - Blood - 427 pages
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albumin Alpha Therapeutic Corporation anti-HCV antibodies batch Baxter Bayer beneﬁts blood safety blood supply Centeon Congressional Testimony centers Chairman clinical Committee concentrates contain Creutzfeldt-Jakob disease cryoprecipitate detected developed disease donations donor exposure donor pool ethanol Factor IX Factor VIII FELDMAN ﬁnal product ﬁrst ﬁve FOURNEL fractionation globulin GOMPERTS hemophilia hepatitis IGIV immune immunodeﬁciency immunoglobulin impact improve industry infection infectious agent intravenous intravenous immunoglobulin ionic strength IPPIA issue laboratory limit liters manufacturing manufacturing practices methods notiﬁcation number of donors patients plasma derived products plasma pool plasma products plasma-based therapies plasmapheresis pool sizes potential Preston product recalls protein prothrombin recalls recipients recovered plasma Red Cross reduce result risk Satcher scientiﬁc scrapie SHAYS signiﬁcant SNOWBARGER Solvent Detergent Source Plasma speciﬁc studies subcommittee surveillance testing tion transfusion transmission treatment units viral inactivation virus viruses