Slide1 l.jpg
Sponsored Links
This presentation is the property of its rightful owner.
1 / 26

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 PowerPoint PPT Presentation


  • 146 Views
  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

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

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


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 ObservationsFY-2008 (Oct. ’07 through Sept. ’08) - continued


Top 10 Blood & Blood Component ObservationsFY-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 - http://www.fda.gov/foi/warning.htm

      ADL - http://www.fda.gov/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 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


Questions

Please join in the Q & A session

at the conclusion

of this morning’s session.


  • Login