Food and Drug Administration
March 18-19, 2004
Briefing Information
Topic I. Clinical Trials for Licensing HepatitisB Immune Globulin Intravenous as Treatment to Prevent HBV Liver Disease Following Liver Transplantation in HBV+ Recipients.
Issue Summary for Topic I (HTM) (PDF) (Word)
Topic II. Supplemental Testing for Human Innune Deficiency Virus (HBV) and Hepatitus C Virus (HCV)
Issue Summary, Supplemental Testing for HIV and HCV (HTM) (PDF) (Word)
Incorporation of NAT into Supplemental and HCV & HIV Seroreative Donors (HTM) (PPT)
Supplemental Testing of Donors for HIV & HCV, Dr. Indira Hewlett, PhD and Dr. Robin Biswas, MD (HTM) (PPT)
Guideline for Laboratory Testing and Result Reporting for Antibody to Hepatitus C Virus, Dr. Kuhnert for Dr. Miriam Alter, PhD (HTM) (PPT)
Supplemental Testing for HIV-1 and HCV, Dr. Susan Stramer, PhD (HTM) (PPT)
Topic III. FDA's Current Thinking on Product Standards, Quality Assurance, and Submission Requirements for Platelets, Pheresis