Transmissible Spongiform Encephalopathies Advisory Committee
February 12 - 13, 2004 Meeting
Date and Time:
The meeting will be held on February 12, 2004, 8:00 am to 5:30 pm; and February 13, 2004, 8:00 am to 3:30 pm.
Location:
Holiday Inn, 8777 Georgia Avenue, Silver Spring, MD, 301-589-0800.
Contact Persons:
William Freas, Ph.D. or Sheila D. Langford, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On February 12, 2004, the Committee will hear an informational presentation on the presumptive transfusion-transmitted case of variant Creutzfeldt-Jakob Disease (vCJD) reported recently in the United Kingdom, and hear updates on related experimental studies in animals on transmission of TSE agents by blood, and relevant epidemiology of human TSE's. In the afternoon, the Committee will receive an update on the case of bovine spongiform encephalopathy (BSE) recently recognized in the United States, and will have a general discussion about potential models of risk-based approaches to sourcing of bovine materials used to make medical products. On February 13, 2004, the Committee will have a preliminary discussion about FDA's current recommendations on measures to minimize risk from TSE agents in various types of medical products.
Oral Presentations:
Between approximaterly 11:30 a.m. and 12:00 noon, and 3:00 and 3:30 p.m. on February 12, 2004; and 11:00 a.m. and 12:00 noon on February 13, 2004, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 9, 2004.
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