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June 13-14, 2002 Meeting
Date and Time:
The meeting will be held on June 13-14, 2002, 8:00 a.m. on both days.
Location:
Gaithersburg Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD 20877, 301-948-8900.
Contact:
Linda A. Smallwood, Ph.D., 301-827-3514, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 19516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On June 13, 2002, committee updates on end user notification and HIV rapid tests are tentatively scheduled. The committee will hear an informational presentation on the shortage of western blot tests for HIV and electronic submission of biological license applications (BLA), and discuss and provide recommendations on standards for recovered plasma. In the afternoon, the committee will hear presentations, discuss and make recommendations on the uniform donor history questionnaire. On June 14, 2002, the following committee updates are tentatively scheduled: summaries of FDA/PPTA workshop on comparability of plasma derivatives, and the AABB conference on oxygen therapeutics. The committee will hear an informational presentation on premarket submissions: in-vitro diagnostic software and instruments. The committee will hear presentations, discuss and make recommendations on the warning label for hetastarch and bleeding.
Oral Presentations:
Between approximately 12:30 p.m. and 1:00 p.m., and 4:00 p.m. and 4:30 p.m. on June 13, 2002; and 12:00 noon and 12:30 p.m. on June 14, 2002, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before June 3, 2002.
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