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Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

December 15, 2006


Update: Status of FDA's Initiative on Communication of the Potential Exposure to vCJD Risk from an Investigational Product, Plasma Derived Factor XI that was Manufactured from UK Donor Plasma, M. Weinstein, Ph.D., FDA (ppt) (htm)

Topic I.  FDA's risk assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products and communication materials. Introduction:  FDA risk management strategy for potential exposure to vCJD in plasma derivatives, D. Scott, M.D., FDA (ppt) (htm)

Risk assessment and interpretation, S. Anderson, Ph.D., FDA (ppt) (htm)

Overall risk communication approach, M. Weinstein, Ph.D., FDA (ppt) (htm)

Patient advocate perspectives, Janice Hamilton, Hemophilia Federation of America (ppt) (htm)

Patient advocate perspectives, Mark Skinner, World Federation of Hemophilia (ppt) (htm)

Topic II.  Levels of TSE clearance in the manufacture of plasma-derived FVIII .  Summary of 18 September 2006 TSEAC discussion, D. Scott, M.D., FDA (ppt) (htm)

Updated information from manufacturers, T. Kreil, Ph.D., PPTA  Baxter Bioscience (ppt) (htm)

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