Food and Drug Administration

Blood Products Advisory Committee

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

Issue Summary for Topic III (HTM) (PDF) (Word)