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From: TSS ()
Subject: TSE ADVISORY COMMITTEE DECEMBER 15, 2006
Date: November 27, 2006 at 3:06 pm PST

Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee
December 15, 2006

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

Topic I: FDA's Risk Assessment for Variant Creutzfeldt- Jakob Disease (vCJD) Potentially Associated with the Use of US Licensed Human Plasma-Derived Factor VIII (pdFVIII, Antihemophilic Factor) Products, and Potential Public Health Service Responses (pdf)

http://www.fda.gov/OHRMS/DOCKETS/ac/06/briefing/2006-4271B1-01.pdf

Draft Quantitative Risk Assessment of vCJD Risk Potentially Associated with the Use of Human Plasma-Derived Factor VIII Manufactured Under United States (US) License From Plasma Collected in the US (pdf)

http://www.fda.gov/OHRMS/DOCKETS/ac/06/briefing/2006-4271B1-02.pdf

Appendex A: Supplemental Technical Information for the FDA Risk Assessment (pdf)

http://www.fda.gov/OHRMS/DOCKETS/ac/06/briefing/2006-4271B1-03.pdf

Topic II: Experimental Clearance of Transmissible Spongiform Encephalopathy (TSE) Infectivity in Plasma-derived Factor VIII (pdFVIII) Products (pdf)

http://www.fda.gov/OHRMS/DOCKETS/ac/06/briefing/2006-4271B1-04.pdf

Bibliography (pdf)

http://www.fda.gov/OHRMS/DOCKETS/ac/06/briefing/2006-4271B-bib.pdf

http://www.fda.gov/OHRMS/DOCKETS/ac/06/briefing/2006-4271b1-index.htm

TSS

• SEE DOCKET BRIEFING

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