|
March 13-14, 2003 Meeting
Date and Time:
The meeting will be held on March 13, 2003 from 8:00 a.m. until 6:00 p.m.; and on March 14, 2003 from 8:30 a.m. until 4:00 p.m.
Location:
Gaithersburg Hilton, Grand Ballrooms A-D, 620 Perry Parkway, Gaithersburg, MD 20877, 301-977-8900.
Contact Person:
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 March 13, 2003, the following committee updates are tentatively scheduled: FDA consolidation, Medical Device User Fee and Modernization Act (MDUFMA), Clinical Laboratory Improvement Amendments (CLIA) waiver for human immunodeficiency, type 1 (HIV-1) rapid tests, and Trans Net pilot program. The committee will hear presentations, discuss and provide recommendations on the topic of West Nile Virus (WNV) testing. On March 14, 2003, the following committee updates are tentatively scheduled: limitations on validation of anti-coagulant and additive solutions to permit freezing and irradiation of red cells, and particulates in blood bags. The committee will hear presentations, discuss and provide recommendations on the topic of extensions of the dating period for pooled platelets.
Oral Presentations:
On March 13, 2003, oral presentations from the public will be scheduled between approximately 9:15 and 9:45 a.m.; and 3:00 and 4:30 p.m. On March 14 , 2003, between approximately 9:00 and 9:30 a.m.; and 10:50 a.m. and 12 noon oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 28, 2003.
|
