Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

October 31, 2005



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Informational Presentations

BSE: Update on Surveillanc, Lisa Ferguson, DVM, APHIS (PDF) (PPT)

Scientific Issues in Evaluating Products Intended to Decontaminate Surgical Instruments Exposed to TSE Agents, Sheila Murphey, MD, FDA (HTM) (PPT)

Topic I

Progress Report on FDa's Risk Assessment for Potential Exposure to vCJD in Human Plasma-derived Antihemophilic Factor (FVIII) Products, Dorothy Scott, MD, FDA (HTM) (PPT)

Varient CJD Risk Associated With Human Plasma Derivatives: Introduction and Overview of Risk Model for US Manufactured Factor VIII, Steven Anderson, PhD, MPP, FDA (HTM) (PPT)

Estimates of the vCJD Epidemic in the UK, Azra Ghani, et. al., London School of Hygiene & Topical Medicine (PDF)

Modeling Risk of vCJD in US Donors - Residual Risk and Efficiency of Donor Deferral, Alan Williams, PhD, FDA (HTM) (PPT)

Possible Range of vCJD Infectivity in Human Plasma: Estimates From Experimental Models, David Asher, MD, FDA (HTM) (PPT)

Review of Publicly Available Information on TSE Clearance by Steps Used to Manufacture FVIII Products, Dorothy Scott, MD, FDA (HTM) (PPT)

Topic II

FVIII Product Usage in Clinical Settings, Mark Weinstein, PhD, FDA (HTM) (PPT)

Labeling Claims for TSE Reduction Studies With Blood Processing Filters, Jaro Vostalk, MD, PhD, FDA (HTM) (PPT)

Evaluation of Prion Reduction Filters (PDF) (PPT)

Removal of TSE Infectivity From Blood by Adsorption to Immobilized Ligands, Robert Rohwer, PhD, VA Medical Center (PDF)

Open Public Hearing

Requests to Speak (HTM) (PDF)

CJD Foundation, Inc. - Medical Education Project (PDF)