Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
April 5-6, 2001 Meeting
Date and Time
The meeting will be held on April 5, 2001 from 9:00 am to 6:00 pm; and on April 6, 2001 from 8:30 am to 3:30 pm.
Location
Holiday Inn Bethesda, 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 April 5-6, 2001, the committee will meet to discuss: 1) responses to the March 6, 2000 FDA Gene Therapy Letter (http://www.fda.gov/cber/letters.htm); 2) results of gene therapy clinical site inspections, 3) long-term follow-up of gene therapy patients, and 4) the FDA proposed rule - Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation (http://www.fda.gov/cber/rules.htm). In addition, the committee will receive an update on two research programs in the Division of Cellular and Gene Therapies and the Division of Monoclonal Antibodies, Center for Biologics Evaluation and Research.
Oral Presentations
Between approximately 1:30 to 2:00 pm on April 5, 2001; and 11:00 to 11:30 am on April 6, 2001, oral presentations from the public will be scheduled. Those desiring to make oral presentations should notify the contact person before March 26, 2001.
Closed Committee Deliberations
On April 5, 2001, from 5:15 to 6:00 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 reports of the review of research programs in the Division of Cellular and Gene Therapies and the Division of Monoclonal Antibodies, Center for Biologics Evaluation and Research.
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