FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

 June 28 & 29, 2001  

BRIEFING INFORMATION

FIRST DAY,  Thursday, June 28, 2001, OPEN SESSION

TOPIC 1.  Review of on suitability of blood donors who have lived or traveled in various countries based on recent information concerning new-variant Creutzfeldt-Jakob disease (vCJD) and bovine spongiform encephalopathy (BSE)

Summary   pdf   html

Action Plan   pdf   html

Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products   pdf

TOPIC 2.  Safety of FDA-Regulated Plasma Derivatives Prepared in Establishments Proposing to Use on the Same Manufacturing Line, Plasma Which Does and Plasma Which Does Not Comply with Potential European Donor Deferrals for vCJD Risk Factors   pdf   html