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Advisory Committees

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Resources for You

2009 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee

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May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Briefing Information

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Topic 1

May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Briefing Information: Topic 1 - Potential for Chlamydia trachomatis and Neisseria gonorrhoeae transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are recovered from the reproductive system, gestational tissues, or other sources (PDF - 236KB)
May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Briefing Information: Topic 1 - Bibliography (PDF - 69KB)

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Topic 2

May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Briefing Document: Topic 2 - Animal Models for Porcine Xenotransplantation Products Intended to Treat Type 1 Diabetes or Acute Liver Failure (PDF - 107KB) Animal Models for Porcine Xenotransplantation Products Intended to Treat Type 1 Diabetes or Acute Liver Failure
May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Briefing Information: Topic 2 - Bibliography (PDF - 68KB)

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Topic 3

May 14-15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Briefing Information: Briefing Document and Questions to AC Panel (PDF - 1.5MB) Clinical issues related to the FDA draft guidance “Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage”
May 15, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Background Comments, Question 1, Topic III - Clinical issues related to the FDA draft guidance "Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage" (PPT - 89KB)
Brent A. Blumenstein, PhD

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