Advisory Committees
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November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Webcast
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Webcasts of the meeting
Call to Order and Introduction of committee - Steven Dubinett, M.D., Chair
Time: 00:00:01Conflict of Interest Statement - Gail Dapolito, Designated Federal Officer
Time: 00:00:20Introductions
Time: 00:03:40Apligraf (Oral), Organogenesis, Inc., BLA 125400
Time: 00:09:14Introduction - Patrick Bilbo
Time: 00:09:22Conditions and Treatments - David Cochran, D.D.S., M.S., Ph.D.
Time: 00:26:20Clinical Efficacy and Safety - Damien Bates, M.D., Ph.D., FRACS (Plast.)
Time: 00:43:02Benefit/Risk Summary - Michael McGuire, D.D.S.
Time: 01:13:55Conclusions - Patrick Bilbo
Time: 01:22:56Q&A
Time: 01:24:03FDA Presentation
Time: 02:30:57Product Quality - Mark H. Lee, Ph.D.
Time: 02:31:20Overview of Periodontal Conditions and Treatments - Robert S. Betz, D.D.S., Captain (Ret), USPHS
Time: 02:48:07Clinical Study Design and Safety and Efficacy - Agnes Lim, M.D.
Time: 03:00:14Q&A
Time: 03:24:07Open Public Hearing
Time: 04:10:10Committee Discussion of Questions and Vote
Time: 04:10:41Adjourn
Time: 06:13:14
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