TISSUE ENGINEERING AND TRANSGENIC ANIMALS

Author:Steven R. Bauer, Ph.D
Division of Cellular and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration

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Table of Contents

  1. TISSUE ENGINEERING AND TRANSGENIC ANIMALS
  2. Transgenic Animal Based Therapeutics
  3. Tissue Engineering and Transgenic Animals
  4. Recent Examples
  5. Gene Targeting
  6. Regulatory Concerns Common to all Biologicals
  7. REGULATORY CONCERNS RELATED TO BIOLOGICALS FROM TRANSGENEIC ANIMALS
  8. XENOTRANSPLANTATION RAISES PUBLIC HEALTH CONCERNS
  9. PHS Guideline on Infectious Disease Issues in Xenotransplantation
  10. Generation/Characterization of Transgenic Animals
  11. Stability of Transgene
  12. Long-term availability of a useful strain
  13. Tissue Engineered Animals Unique Regulatory Considerations
  14. FDA DOCUMENTS RELATED TO USE OF TRANSGENIC ANIMALS

| MATES June 15th Meeting Agenda |