FDA Presentations

• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Slide Index (PDF - 20KB)
• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Presentation: Animal Models For Evaluation of Porcine Cells/Tissues to Treat Patients With Acute Liver Failure (PPT - 3.5MB)
  Fox
• May 15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Update on OCTGT Guidance Development Program (PPT - 229KB)
  Richard McFalrand, PhD, MD
• May 15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Discussion of Clinical Issues to be Considered in Finalization of the FDA Draft Guidance for Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PPT - 67KB)
  Richard McFalrand, PhD, MD
• May 14, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) Infections of HCT/Ps Recovered From the Reproductive System, Gestational Tissues or Other Sources – Literature Review (PPT - 224KB)
  Ana Kolin, Ph.D.
• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Animal Models for Porcine Xenotransplantation Products Intended to Treat Type 1 Diabetes or Acute Liver Failure (PPT - 120KB)
  Serabian
• May 14, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Chlamydia Trachomatis and Neisseria Gonorrhoeae Transmission by HCT/Ps Recovered From the Reproductive System, Gestational Tissues or Other Sources: Introduction (PPTM - 197KB)
  Melissa A. Greenwald, M.D.

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• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Animal Models for Evaluation of Porcine Islet Products to Treat Patients with Type 1 Diabetes (PPTX - 1.6MB)
  Bernhard J. Hering
• May 15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Issues Concerning Clinical Outcomes in Long-Term Trials of Cellular Therapies for Cartilage Repair. (PPT - 2MB)
  Gunnar Knutsen MD, PhD
• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Cord Blood Collection and Banking: Overview and Efforts to Minimize Microbial Contamination (PPT - 1.1MB)
  John P. Miller, M.D., Ph.D.
• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Overview of the Infectivity and Epidemiology of Chlamydia Trachomatis and Neisseria Gonorrhoeae (PPT - 2.1MB)
• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Overview of Treatment Options for Articular Cartilage Repair: Past Present and Future (PPT - 5MB) Ken Zaslav, MD
• May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Human Amnion: Current Scope of Utilization (PPT - 22.7MB)
  Scheffer C. G. Tseng, Md, Phd