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Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

December 15, 2006

FDA

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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)

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)

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

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

Bibliography (pdf)

Page last updated November 27, 2006 kkhorizonal rule
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