Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
March 20-21, 2000 Meeting
Date and Time
The meeting will be held on March 20, 2000, 9:00 am to 5:30 pm; and on March 21, 2000, 8:00 am to 4:00 pm.
Location
Holiday Inn, Versailles Ballrooms I and II, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000.
Contact Person
Gail Dapolito or Rosanna Harvey, 301-827-0314 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12389. Please call the Information Line for up-to-date information on this meeting.
Agenda
On March 20-21, the committee will discuss: 1) issues related to the use of human pancreatic islets for the treatment of diabetes, including product development issues relating to the procurement, processing and characterization of islets, preclinical animal models for islets and a brief clinical perspective; and 2) the report of the January 13, 2000, meeting of the Xenotransplantation Subcommittee. Also, the committee will hear an update of research programs in the Division of
Cellular and Gene Therapies and the Division of Therapeutic Proteins.
Oral Presentations
On March 20, between approximately 1:45 and 2:15 pm; and on March 21, between approximately 11:30 am and 12:00 noon oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before March 10.
Closed Committee Deliberations
On March 21, from 8:45 to 9:30 am the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).
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