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Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee

May 14-15, 2009

BRIEFING INFORMATION

Topic I

FDA

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. ( htm)

Bibliography (htm)

Topic II

FDA

Animal Models for Porcine Xenotransplantation Products Intended to Treat 
Type 1 Diabetes or Acute Liver Failure (htm)

Bibliography (htm)

Topic III

FDA

Clinical issues related to the FDA draft guidance “Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage” (pdf)

Page last updated May 12, 2009 kkhorizonal rule
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