Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

October 14, 2004


USDA Licensed Test Kits and Enhanced Surveilance for BSE, Larry Ludemann and Lawrence Elsken, USDA (HTM) (PPT)

BSE: World Situation and USDA Response, Dr. Lisa Ferguson, DVM, USDA (PPT)

Animal Feed Regulations for Prevention of GSE (PPT)

Labeling Claims for TSE Clearance in Plasma Derivative Products, Dr. Dorothy Scott, MD, FDA (HTM) (PPT)

TSE Task Force - Prion Reduction Evaluation in the Manufacturing of Plasma Protein Therapies, Dr. Henry Baron, FDA (HTM) (PPT)

Presumptive Transfusion Transmissions of vCJD: Introduction to Consideration of Current FDA-Recommended Safeguards, Dr. David Asher, MD, FDA (HTM) (PPT)

Coparison of the Transfusion Risk for CJD vs. vCJD, Dr. Steven Anderson, PhD, MPP, FDA (HTM) (PPT)

Removal of Blood-Borne TSE Infectivity by Leukoreduction Filters, Luisa Gregori, VA Medical Center (HTM) (PPT)

Health Canada's Considerations Respecting Proposed New VCJD Risk Reduction Measures for the Blood System, Dr. Peter Ganz, Health Canada (HTM) (PPT)

Current Safeguards for Blood Products Recommended by FDA, Dr. Dorothy Scott, MD, FDA (HTM) (PPT)

Development of FDA Recommendations for Deferral of Donors Based on Risk of BSE Exposure, Dr. Alan Williams, PhD, FDA (PPT)

Open Public Hearing

Performance of the Enfer TSE Test With Front End Automation, Dr. Steve Figard, PhD, Abbott Diagnostics (PPS)

Inovation is in Our Blood, Dr. Alan rudolph, PhD, MBA, Adlyfe Diagnostics (HTM) (PPT)

A Prion Disease Initiation Model Based on a Credible Candidate for Protein X Enables Detection of Human Exposure to BSE, In Serum, Bergumann J, Bergmann R, Janetzky B, Preddie E, Allegen, Inc. (PPT)

Bovine Spongiform Encephalopathy (BSE) Antigen Test Kit, IDEXX Laboratories, Inc. (PDF)

Progress Towards a Feasible Blood Test, Microsens Biotechnologies (PPT)

"CJD Lookback Study" (Research Study to Assess the Risk of Blood Borne Transmission of CJD), Dr. Roger Dodd, PhD, American Red Cross Blood Services (HTM) (PPT)

Statement of G. Fitzpatrick, America's Blood Centers (PDF)

Statement of Haemophilia Action UK (HTM) (PPT) (Word)

Re Exposure to vCJD (HTM) (PPT) (Word)