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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?”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


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Introduction

We will discuss

  • FDA inspection data

  • Fatalities reported to FDA

  • Biological Product Deviation Reports

  • Where (can) should we go?



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


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


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


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


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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.


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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


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Adverse ReactionsRegulatory Requirements, Guidance, Reports






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Biological Product Deviation ReportsRegulatory Requirements, Guidance, Reports











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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


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Questions

Please join in the Q & A session

at the conclusion

of this morning’s session.


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