Food and Drug Administration
February 12, 2004
Slides
Comparison of the Transfusion Risk for CJD vs. vCJD, Dr. Steven Anderson, PhD, MPP, FDA (HTM) (PPT)
BSE in the US APHIS Investigation and Response, Dr. Lisa Ferguson, DVM, USDA (HTM) (PPT)
Overview of New Regulations and Policies to Further Enhance Safeguards Against Bovine Spongiform Encephalopathy (BSE), Mary Porretta, USDA (HTM) (PPT)
Status of U.S. Feed Ban, Dr. Stephen Sundlof, DVM, PhD, FDA (HTM) (PDF) (Word)
Risk-Based Sourcing for Bovine Materials in FDA-Regulated Medical Products: Introduction and General Considerations, Dr. David Asher, MD, FDA (HTM) (PPT)
A Simulation Model to Quantify the Spread of BSE in the United States, Joshua Cohen and George Gray, Harvard School of Public Healty (HTM) (PPT)
Canadian and U.S. BSE Risk, Dr. Steven Anderson, PhD, MPP, FDA (HTM) (PPT)
Open Public Hearing
PPTA Statement on Contribution of Manufacturing Processes to Prion Removal in the Production of Plasma-Derived Therapeutics, Plasma Protein Therapuetics Assoc. (PDF)
Bovine Derived Products Are Safe, Serologicals Corp. (PPT)
Serologicals Patents Process That Inactivates "Mad Cow" Prions, Serologicals Corp. (PDF)
Statement From Daniel Kinburn on Behalf of Physicians Committee for Responsible Medicine (HTM) (PDF) (Word)
Memorandum From Keith Gittermann, Invitrogen Corp. (PDF)
Proteolytic Inactivation of Prions; a Biological Solution to TSE Decontamination, Health Protection Agency, UK (HTM) (PPT)
Removal of Prion (PrP) From Red Cell Concentrates (RCC) With a Prototype of a Prion Removal Filter (PrRF), Pall Corp. (PDF)
Update to Study: Removal of Prion (PrP) From Red Cell Concentrates (RCC) With a Prototype of a Prion Removal Filter (PrRF) (PDF)