FDA Regulation of Blood Safety: Notification, Recall, and Enforcement Practices : Hearing Before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, First Session, June 5, 1997
U.S. Government Printing Office, 1998 - Blood - 300 pages
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Hearing held on June 5 1997
steinhardt Bernice Director Health Services Quality and Public Health
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accident reports adverse event reports albumin B372 Rayburn House Baxter blood and blood blood facilities blood products blood safety system CBER CBER’s Centeon Center Chairman Christopher Shays CHESEMORE Christopher Shays classiﬁcation compliance Creutzfeldt-Jakob disease Deﬁciency disease District Ofﬁce donors ensure Enterobacter cloacae EPSTEIN error and accident factor Factor VIII FDA's FDA’s ﬁndings Finley ﬁrm ﬁrst FRIEDMAN Government Reform hemophilia hepatitis HTLV Human Resources identiﬁed industry infected inspection process inspections of plasma inspectors issue joint inspections licensed manufacturers MedWatch notification Odwalla ORA'S Oversight Committee patient notiﬁcation system percent plasma collection plasma fractionators plasma pools plasma products primary immune deficiency problem product recalls Public Health recommendations Reform and Oversight regulations regulatory Relations B372 Rayburn responsive blood safety risk ROSLEWICZ saline contamination signiﬁcant source plasma speciﬁc STEINHARDT Subcommittee on Human talk paper Thank there’s transfusion unlicensed facilities warning letter withdrawals and recalls