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June 19 - 20, 2003 Meeting
Date and Time:
The meeting will be held on June 19, 2003, 8:00 a.m. to 6:00 p.m.; and June 20, 2003, 8:30 a.m. to 3:00 p.m.
Location:
Hilton Gaithersburg, Grand Ballrooms A,B,C, and D, 620 Perry Parkway, Gaithersburg, MD 20877, 301-977-8900.
Contact Persons:
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:
In open session on June 19, 2003, the committee will hear updates on the following tentative topics: Medical Device User Fee and Modernization Act (MDUFMA), Secure E-mail and Electronic Submissions, White Particulate Matter in Blood Bags, and Safety Reporting Requirements for Human Drug and Biological Products. The committee will further hear informational presentations on Severe Acute Respiratory Syndrome (SARS) and West Nile Virus (WNV). In open session on June 20, 2003, the committee will hear presentations, discuss and provide recommendations on the topic of recovered plasma. In the afternoon, the committee will hear an informational presentation on Vaccinia Immune Globulin Intravenous (VIGIV): current thinking and indications for use.
Oral Presentations:
Between approximately 10:00 a.m. and 10:30 a.m., 1:30 p.m. and 2:30 p.m. on June 19, 2003; and 10:00 a.m. and 10:30 a.m., 2:00 p.m. and 2:30 p.m. on June 20, 2003, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before June 6, 2003.
Closed Committee Deliberations:
On June 19, 2003, from 3:00 p.m. to 6:00 p.m. the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
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