Cellular, Tissue and Gene Therapies Advisory Committee
(Formerly Biological Response Modifiers Advisory Committee)
October 9 - 10, 2003 Meeting
Date and Time:
The meeting will be held on October 9, 2003, 8:00 a.m. to 6:00 p.m.; and October 10, 2003, 8:00 a.m. to 2:00 p.m.
Location:
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD, 301-948-8900.
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:
On October 9-10, 2003, the committee will 1) discuss issues related to manufacturing data and clinical evidence to be provided in a biologics license application (BLA) for marketing approval of allogeneic islet transplantation to treat type 1 diabetes mellitus; 2) hear updates of individual research programs in the Office of Cellular, Tissue and Gene Therapies; and 3) discuss reports of internal research programs in the Office of Cellular, Tissue and Gene Therapies.
Oral Presentations:
Between approximately 1:00 and 1:30 p.m. on October 9, and 10:30 and 11:00 a.m. on October 10, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before October 2.
Closed Committee Deliberations:
On October 9, 2003, from approximately 5:15 and 6:00 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 a report of a review of internal research programs in the Office of Cellular, Tissue and Gene Therapies.
Pancreatic Islet Transplantation to Treat Type I Diabetes
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