Blood Products Advisory Committee
August 16, 2007
Date and Time:
The meeting will be held on August 16, 2007 from 8:00 a.m. to 5:00 p.m.
Location:
Doubletree Hotel and Executive Meeting Center, 8120 Wisconsin Avenue, Bethesda, MD 20814. Their telephone number is 301-652-2000.
Contact Persons:
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 August 16, 2007, the Committee will hear updates on the following topics: (1) summary of the May 10-11, 2007, meeting of the DHHS Advisory Committee on Blood Safety and Availability, (2) summary of the April 25-26, 2007, FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing, and (3) summary of August 15, 2007, FDA Workshop on Licensure of Apheresis Blood Products. The Committee will then hear informational presentations relating to the World Health Organization (WHO) biological standards on the following topics: (1) summary of January 29-30, 2007, WHO meeting with WHO collaborating centers for biological standards and standardization to support the development of WHO biological reference preparations for high risk blood safety-related in vitro diagnostics, (2) potency and safety standards for plasma derivatives and (3) joint FDA/WHO minimum potency standards for certain blood grouping reagents. The Committee will hear the response of the Office of Blood Research and Review to their Office Level Site Visit of July 22, 2005. In the afternoon the Committee will discuss measles antibody levels in U.S. Immune Globulin products.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 11:15 a.m. to 11:45 a.m. and between approximately 3:30 p.m. to 4:00 p.m. on August 16, 2007. Those desiring to make formal oral presentations should notify the contact person on or before, July 31, 2007.