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U.S. Department of Health and Human Services

Advisory Committees

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February 26, 2014: Cellular, Tissue, and Gene Therapies Advisory Committee Meeting: Draft Agenda

Food and Drug Administration
Cellular, Tissue and Gene Therapies Advisory Committee
Meeting #59
February 25-26, 2014

Draft Agenda: Wednesday, February 26, 2014
8:00 a.m. Opening Remarks
Topic I:  Oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility
8:15 Committee Discussion of Questions (cont’d)
Topic II – Update of Guidance Documents Issued by Office of Cellular, Tissue and Gene Therapies, CBER, FDA
11:15 a.m. FDA Guidance Update
11:35 Recognition of Committee Service
11:55 a.m. Adjourn Session
Topic III – Draft Guidance for Industry:  Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
12:55 p.m. FDA Introduction
1:10 FDA Presentation
1:50 Open Public Hearing
2:20 Break
2:35 Committee Discussion of Questions
5:00 p.m. Adjourn Meeting