Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
October 10, 2002
Date and Time
The meeting will be held on October 10, 2002, 8:00 a.m. to approximately 5:30 p.m.
Location
Hilton Hotel, Grand Ballroom A-B-C-D, 620 Perry Parkway, Gaithersburg, MD, 20877, 301-977-8900
Contact Persons
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
The committee will discuss safety issues recently identified related to retrovirus vectors in gene therapies for the treatment of patients with severe combined immune deficiency disease and receive updates on individual research programs in the Division of Cell and Gene Therapies and the Division of Therapeutic Proteins.
Oral Presentations
Between approximately 11:30 a.m. to 12:30 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before October 9, 2002.
Closed Committee Deliberations
From approximately 5:00 p.m. to 5:30 p.m. 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 individual research programs in the Center for Biologics Evaluation and Research.
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