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March 18 - 19, 2004 Meeting
Date and Time:
The meeting will be held on March 18, 2004, 8:00 a.m. to 5:00 p.m.; and on March 19, 2004, 8:00 a.m. to 3:00 p.m.
Location:
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD, 301-984-8900.
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 3014519516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On March 18, the committee will hear presentations, discuss and provide recommendations on clinical trials for licensing hepatitis B immune globulin as treatment to prevent hepatitis B virus (HBV) liver disease following liver transplantation in HBV+ recipients. The committee will also hear updates on the following topics: summary of the Public Health Service Advisory Committee on Blood Safety and Availability meeting; summary of the Transmissible Spongiform Encephalolpathies Advisory Committee meeting; current thinking on draft guidance for nucleic acid testing (NAT) human immune deficiency virus (HIV) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and re-entry; current thinking on final guidance for use of NAT on pooled and individual samples from donors of whole blood and blood components to adequately and appropriately reduce the risk of transmission of HIV-1 and HCV; and current thinking on variances to address the specificity issues of Ortho HbsAg 3.0 assays. In the afternoon, the committee will hear presentations, discuss and provide recommendations on supplemental testing for HIV and HCV. On March 19, the committee will hear presentations, discuss and provide recommendations on platelet apheresis quality control; and hear presentations relevant to the site visit report on the review of the research programs of the Laboratory of Hepatitis and Emerging Bacterial Agents and the Laboratory of Bacterial, Parasitic, and Unconventional Agents.
Oral Presentations:
Between approximately 9:30 and 10:00 a.m., and 3:45 and 4:15 p.m. on March 18; and 9:30 to 10:00 a.m. on March 19, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 27, 2004.
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