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July 21, 2005 Meeting
Date and Time:
The meeting will be held on July 21, 2005; 8:00 a.m. to approximately 6:30 p.m.
Location:
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD 20879; 301-948-8900.
Contact Persons:
William Freas, Ph.D. or Pearline Muckelvene, 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:
In the morning, the Committee will hear updates on the following topics: (1) Summary of the May 2005 meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) disseminated intravascular coagulation associated with acute hemoglobinemia following anti-D Immune Globulin Intravenous administration for idiopathic thrombocytopenic purpura; (3) update on safety of albumin; (4) summary of June 2005 workshop on Biological Therapeutics for Rare Plasma Protein Disorders; (5) summary of July 2005 workshop on Leukoreduction and updates on West Nile Virus guidance. The Committee will discuss management of donors and units that test positive for Hepatitis B Virus DNA by nucleic acid tests. In the afternoon, the Committee will discuss the scientific basis for review of Varicella Zoster Immune Globulin and Dextran 1 pre-treatment for safe use of Dextran 40/70.
Oral Presentations:
Between approximately 10:30 and 11:00 a.m; 2:30 and 3:00 p.m; and 5:00 and 5:30 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person by July 13, 2005.
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