Blood Products Advisory Committee
May 1-2, 2008
Date and Time:
The meeting will be held on May 1, 2008 from 8:30 a.m. to 5:30 p.m. and on May 2, 2008 from 8:30 a.m. to 4:00 p.m.
Location:
Hilton Hotel, Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person:
Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, HFM-71, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On the morning of May 1, 2008, the Committee will hear updates on the following: (1) Summaries of August 22-23, 2007, and January 9-10, 2008, meetings of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) 2007 West Nile Virus Epidemiology and the use of nucleic acid tests to reduce the risk of transmission of West Nile Virus in Whole Blood and blood components for transfusion and Human Cells, Tissues, and Cellular and Tissue-based products (HCT/Ps); (3) implementation of blood donor screening for infection with Trypanosoma cruzi and the use of serological tests to reduce the risk of transmission of T. cruzi infection in Whole Blood and blood components for transfusion and Human Cells, Tissues, and Cellular and Tissue-based products (HCT/Ps); (4) FDA's proposal to lower the minimum recommended lot release titer for measles antibodies in Immune Globulin Intravenous (Human) (IGIV) and Immune Globulin Subcutaneous (Human) (IGSC); (5) Gambro/Fenwal Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post Marketing Study - 7 Day Platelets; (6) Experience with 7 Day Platelets Versus 5 Day Platelets; (7) FDA Perspective on the PASSPORT Study. These updates will be followed by informational presentations on Center for Biologics Evaluation and Research Safety Teams related to blood and tissue.
In the afternoon the Committee will discuss the Biomedical Excellence for Safer Transfusion Committee Report on red blood cell recovery standards.
On the morning of May 2, 2008, the Committee will discuss Lev Pharmaceutical's plasma-derived C1 esterase inhibitor (Cinryze). Then, in the afternoon the Committee will review the research programs in the Laboratory of Hepatitis and Related Emerging Agents, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, CBER Site Visit of November 8, 2007.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 11:50 a.m. and 12:20 p.m. and between approximately 4:20 p.m. and 4:50 p.m. on May 1, 2008 and between approximately 10:40 a.m. and 11:10 a.m. and 2:40p.m. and 3:00 p.m. on May 2, 2008. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 23, 2008.