Food and Drug Administration
February 8, 2005
Briefing Information
Topic 1: Possible vCJD Risk From Investigational Coagulation Factor XI Manufactured in the 1990's From Plasma of Donors Residing in the United Kingdom (UK) (HTM) (PDF) (Word)
Draft Risk Assessment: Potential Exposure to the vCJD Agent in United States Recipients of Factor XI Coagulation Product Manufactured in the United Kingdom (HTM) (PDF) (Word)
Topic 2: Risk Assessment Model for Potential Risk of Exposure to Variant Creutzfeldt-Jakob Disease (vCJD) Agent in Plasma Products (HTM) (PDF) (Word)
Topic 3: Deferral of Blood and Plasma Donors for History of Transfusion in European Countries (HTM) (PDF) (Word)