Transmissible Spongiform Encephalopathies Advisory Committee
July 17-18, 2003 Meeting
Date and Time:
The meeting will be held on July 17, 2003, 8:00 a.m. to 6:00 p.m.; and July 18, 2003, 8:00 a.m. to 4:30 p.m.
Location:
Holiday Inn-Select, 8120 Wisconsin Avenue, Bethsda, Maryland, 20814, 301-652-2000.
Contact Person:
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 12392. Please call the Information Line for up-to-date information on this meeting.
Agenda:
On July 17, 2003, the Committee will discuss the safety of bovine gelatin in oral and topical drugs, food and cosmetics. The Committee will then discuss bovine spongiform encephalopathy in Canada and potential implications for FDA-regulated products. In the afternoon, the Committee will hear presentations on transmissible spongiform encephalopathies (TSEs) and decontamination of medical equipment and facilities. On July 18, 2003, the Committee will discuss designing, interpreting, and validating studies to evaluate reprocessing methods for removing TSE contamination from medical devices. In the afternoon, the Committee will discuss methods to decontaminate facilities and equipment used to prepare human cellular and tissue products, and human blood products, including plasma derivatives, to reduce the theoretical risk of transmitting TSE agents.
Oral Presentations:
Between approximately 11:35 and 11:55 a.m, and 1:55 and 2:25 p.m. on July 17; and 9:50 and 10:20 a.m., and 1:30and 2:00 p.m. on July 18, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before July 11, 2003.
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