Proposed Approach to Regulation of Cell and Tissue-Based Products: A Framework

Author: Martha A. Wells
CBER, FDA

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Table of Contents

  1. Proposed Approach to Regulation of Cell and Tissue-Based Products: A Framework
  2. Biological Products Regulated by CBER
  3. Human Cells and Tissue Regulatory Basis
  4. Human Cells and Tissue Regulatory Basis
  5. FDA’s Proposed Approach February 1997
  6. Regulatory Concerns
  7. Product Characteristics
  8. Current Activities
  9. Current Activities
  10. Tissue Reference Group (TRG)
  11. TRG
  12. TRG Recommendations

| MATES June 15th Meeting Agenda |