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Advisory Committees

September 22, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Agenda

Food and Drug Administration
Center for Biologics Evaluation and Research
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting # 53, September 22, 2011
Hilton Hotel, Gaithersburg, MD

Draft Agenda

8:00 a.m.Call to order and Introduction of Committee
Evan Snyder, M.D., Ph.D., Acting Chair
Conflict of Interest Statement
Gail Dapolito, Designated Federal Officer
 Open Committee Discussion: BLA 125397, Umbilical Cord Blood, New York Blood Center, indicated for hematologic malignancies, bone marrow failure, primary immunodeficiency diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-linked adrenoleukodystrophy
8:10FDA Introduction
8:15Sponsor Presentation
National Cord Blood Program at the
Howard P. Milstein Cord Blood Center
9:15Q&A
9:30Break
9:45FDA Presentation
10:45Q&A
11:00Open Public Hearing
12 noonLunch
1:00 p.m.Committee Discussion of Questions
5:00 p.m.Adjourn

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