Cellular, Tissue and Gene Therapies Advisory Committee: Center for Biologics Evaluation and Research, Food and Drug Administration

摘要

Contents: Call to Order; Conflict of Interest Statement; Introduction of Committee; FDA Introduction; Organogenesis, Inc.: Introduction; Conditions and Treatments; Clinical Efficacy and Safety; Benefit/Risk Summary, and Conclusions; FDA Presentation: Product Quality, Overview of Periodontal Conditions and Treatments, and Clincal Study Design and Safety and Efficacy, and Open Public Hearing.