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
8:10	FDAIntroduction
8:15	Regulation of Humanitarian Device Exemption (HDE) products
8:40	Q&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
9:50	Q&A
10:05	Break
10:20	FDA Presentation
11:20	Q&A
11:35	Open Public Hearing
12:35 p.m	Lunch
1:30	Committee Discussion of Questions and Vote
5:00 p.m.	Adjourn