Advisory Committees

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
8:15Committee 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
11:35Recognition 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Topic III – Draft Guidance for Industry:  Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products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
1:10FDA Presentation
1:50Open Public Hearing
2:20Break
2:35Committee Discussion of Questions
5:00 p.m.Adjourn Meeting

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