Transmissible Spongiform Encephalopathies Advisory Committee
October 31, 2005 Meeting
Date and Time:
The meeting will be held on October 31, 2005, 8:00 a.m. to 5:30 p.m.
Location:
Holiday Inn Select, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000.
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:
The Committee will hear updates on the following topics: Current status of bovine spongiform encephalopathy (BSE) in the United States, incidence and prevalence worldwide of variant Creutzfeldt-Jakob Disease (vCJD), and a summary of the FDA Device Panel discussion on September 27, 2005 on criteria for considering label claims of effective decontamination for surgical instruments exposed to TSE agents. The Committee will then discuss progress in development of a risk assessment model for variant Creutzfeldt-Jakob Disease in United States-licensed human plasma-derived Antihemophilic Factor (Factor VIII). The latter discussion will focus on selection of input parameters for the model. In the afternoon, the Committee will discuss labeling claims for transmissible spongiform encephalopathy (TSE) clearance studies for blood component filters.
Oral Presentations:
Between approximately 12:30 and 1:00 p.m., and 4:15 and 4:45 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before October 25, 2005.
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