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FDA Perspective - U S Food and Drug Administration Home PageFDA的角度-美国食品和药物管理局的主页.ppt

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FDA Perspective - U S Food and Drug Administration Home PageFDA的角度-美国食品和药物管理局的主页

FDA perspective on “Where are we?Where can we go?”12th Annual FDA the Changing Paradigm for Blood Regulation16 January 2009 -- Las Vegas, NV Gilliam B. Conley Director, Division of Inspections Surveillance FDA, Center for Biologics Evaluation Research Office of Compliance Biologics Quality Introduction We will discuss FDA inspection data Fatalities reported to FDA Biological Product Deviation Reports Where (can) should we go? FY-2008 Inspections Conducted Top 10 Biologics ObservationsFY-2008 (Oct. ’07 through Sept. ’08) Top 10 Blood Blood Component ObservationsFY-2008 (Oct. ’07 through Sept. ’08) Top 10 Blood Blood Component Observations FY-2008 (Oct. ’07 through Sept. ’08) - continued Top 10 Blood Blood Component Observations FY-2008 (Oct. ’07 through Sept. ’08) - continued Inspection Classification – FY-2008 Note: These numbers represent a snapshot in time from our inspections database. Because of the further routine review following an investigator’s initial recommendation for an OAI inspection decision, the year-end actual numbers are fewer than the 14 reported here. Regulatory Actions – FY-2008 Warning Letters 1 – Source Plasma 3 – transfusion services or blood centers Adverse Determination Letters 1 – issued under consent decree covered multiple facility inspections Find on the web: WL - /foi/warning.htm ADL - /ora/frequent/default.htm Adverse ReactionsRegulatory Requirements, Guidance, Reports Transfusion-related fatalities Reports of TRALI by implicated Blood Product Hemolytic Transfusion Rx. Microbial Infection by Implicated Organism Biological Product Deviation ReportsRegulatory Requirements, Guidance, Reports BPDR for Blood Blood Components Biological Product Deviation Reporting Blood Establishments Blood Establishments Blood Establishments Plasma Establishments Plasma Establishments Plasma Establishments Donors who subsequently test positive for viral marker Where (can) should we go? We will continue to gather inform