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September 23, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Draft Agenda

Food and Drug Administration
Center for Biologics Evaluation and Research
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting # 53, September 23, 2011
Hilton Hotel, Gaithersburg, MD

Draft Agenda

8:00 a.m.Call to Order and Introduction of Committee
 Conflict of Interest Statement
8:10FDAIntroduction
8:15Regulation of Humanitarian Device Exemption (HDE) products
8:40Q&A

Open Committee Discussion: HDE BH110018, CliniMACS® CD34 Selection System, Miltenyi Biotec, for processing allogeneic HLA-matched hematopoietic progenitor cells-apheresis (HPC-C) from a related donor to obtain a CD34 + cell population intended for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis in patients with acute myelogenous leukemia in first or second morphologic complete remission

8:50

Sponsor Presentation
Miltenyi Biotec, Incorporated

9:50Q&A
10:05Break
10:20FDA Presentation
11:20Q&A
11:35Open Public Hearing
12:35 p.mLunch
1:30

Committee Discussion of Questions and Vote

5:00 p.m.Adjourn