STEM CELLS

Author: Liana Harvath, Ph.D.
Division of Cellular and Gene Therapies
Office of Therapeutics Research and Review
CBER

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Table of Contents

  1. STEM CELLS
  2. Stem/Progenitor Cells
  3. Active Investigation
  4. Hematopoietic Stem/Progenitor Cell Product INDs
  5. Potential Therapeutic Areas
  6. Laws and Policy Applicable to Stem Cell Products
  7. A New Class of Product Requiring INDs
  8. Current Regulation of Stem Cells
  9. Proposed Regulation of Hematopoietic Stem Cells
  10. Hematopoietic Stem Cell Standards Development
  11. If sufficient data are not available to develop standards,
  12. If FDA determines that data are available to support the development of standards,
  13. Public Workshop
  14. FDA Biological Response Modifiers Advisory Committee Meeting

| MATES June 15th Meeting Agenda |