Webcasts of the meeting
Call to Order and Introduction of committee - Steven Dubinett, M.D., Chair
Conflict of Interest Statement - Gail Dapolito, Designated Federal Officer
Apligraf (Oral), Organogenesis, Inc., BLA 125400
Introduction - Patrick Bilbo
Conditions and Treatments - David Cochran, D.D.S., M.S., Ph.D.
Clinical Efficacy and Safety - Damien Bates, M.D., Ph.D., FRACS (Plast.)
Benefit/Risk Summary - Michael McGuire, D.D.S.
Conclusions - Patrick Bilbo
Product Quality - Mark H. Lee, Ph.D.
Overview of Periodontal Conditions and Treatments - Robert S. Betz, D.D.S., Captain (Ret), USPHS
Clinical Study Design and Safety and Efficacy - Agnes Lim, M.D.
Open Public Hearing
Committee Discussion of Questions and Vote