Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

June 26, 2002

Briefing Information

Issue Summary - Topic #1

Validation of Procedures to Prevent Contamination and Cross-Contamination with TSE Agents of Human Tissue Intended for Transplantation  doc  pdf  ppt

FDA Draft Guidance on Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products  doc pdf

Limiting Batch Size: Effects of Batch Size on Risk of Contamination with Infectious Agents, Dr. Thomas Lynch, PhD, Clearant, Inc.  doc  pdf

Bibliography  doc  pdf

Topic #2

Issue Summary pdf doc

Draft Issue Summary: FDA Draft Guidance on Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products  doc  pdf