Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
July 15, 1999 Meeting
Date and Time
The meeting will be held on July 15, 1999 from 8:00 am to 5:45 pm.
Location
Bethesda Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000.
Contact Person
Gail Dapolito or Rosanna L. 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
In the open session, the committee will discuss the following issues: 1) an update of FDA regulatory policy concerning the implications on biological product development of fast track and the recent pediatric rule, 2) a scientific discussion concerning immune reactions to therapeutic and diagnostic biological products and 3) the report of the June 3-4, 1999 meeting of the Xenotransplantation Subcommittee.
Oral Presentations
Between approximately 8:10 and 9:10 am oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before July 8, 1999.
Closed Committee Deliberations
From 4:00 to 5:00 pm 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)). The committee will discuss a site visit report of research programs in the Office of Therapeutics Research and Review.
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