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FDA perspective on “Where are we? Where can we go?” 12 th Annual FDA & the Changing Paradigm for Blood Regulation

FDA perspective on “Where are we? Where can we go?” 12 th Annual FDA & the Changing Paradigm for Blood Regulation 16 January 2009 -- Las Vegas, NV. Gilliam B. Conley Director, Division of Inspections & Surveillance FDA, Center for Biologics Evaluation & Research

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FDA perspective on “Where are we? Where can we go?” 12 th Annual FDA & the Changing Paradigm for Blood Regulation

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  1. 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

  2. Introduction We will discuss • FDA inspection data • Fatalities reported to FDA • Biological Product Deviation Reports • Where (can) should we go?

  3. FY-2008 Inspections Conducted

  4. Top 10 Biologics ObservationsFY-2008 (Oct. ’07 through Sept. ’08)

  5. Top 10 Blood & Blood Component ObservationsFY-2008 (Oct. ’07 through Sept. ’08)

  6. Top 10 Blood & Blood Component ObservationsFY-2008 (Oct. ’07 through Sept. ’08) - continued

  7. Top 10 Blood & Blood Component ObservationsFY-2008 (Oct. ’07 through Sept. ’08) - continued

  8. 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.

  9. 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 - http://www.fda.gov/foi/warning.htm ADL - http://www.fda.gov/ora/frequent/default.htm

  10. Adverse ReactionsRegulatory Requirements, Guidance, Reports

  11. Transfusion-related fatalities

  12. Reports of TRALI by implicated Blood Product

  13. Hemolytic Transfusion Rx.

  14. Microbial Infection by Implicated Organism

  15. Biological Product Deviation ReportsRegulatory Requirements, Guidance, Reports

  16. BPDR for Blood & Blood Components

  17. Biological Product Deviation Reporting

  18. Blood Establishments

  19. Blood Establishments

  20. Blood Establishments

  21. Plasma Establishments

  22. Plasma Establishments

  23. Plasma Establishments

  24. Donors who subsequently test positive for viral marker

  25. Where (can) should we go? • We will continue to gather information • We will continue to report information(web based information, public presentations, …) • We are interested in learning: • How do you use FDA’s posted data? • Analyze with own data? • Institute quality change? • Which FDA-posted data is most useful? • What are your success stories?Please find a way to share with others

  26. Questions Please join in the Q & A session at the conclusion of this morning’s session.

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