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U.S. Department of Health and Human Services

Advisory Committees

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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
8:10 FDA Introduction
8:15 Sponsor Presentation
National Cord Blood Program at the
Howard P. Milstein Cord Blood Center
9:15 Q&A
9:30 Break
9:45 FDA Presentation
10:45 Q&A
11:00 Open Public Hearing
12 noon Lunch
1:00 p.m. Committee Discussion of Questions
5:00 p.m. Adjourn