Regulatory Approach for Gene Therapy

Author: Carolyn A. Wilson, Ph.D.
Division of Cellular and Gene Therapies
Office of Therapeutics, Research and Review
CBER/FDA

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Table of Contents

  1. Regulatory Approach for Gene Therapy
  2. Definition
  3. Applications of Gene Transfer to Tissue Engineering
  4. Tools of Ex vivo Gene Therapy
  5. Who Regulates Gene Transfer Research?
  6. Gene Transfer Protocols Reviewed by FDA Since 1989
  7. Unique Regulatory Considerations of Gene Transfer Clinical Protocols
  8. Regulation of Biological Products Based on Sound Science, Law and Public Health Impact
  9. Guidance Documents
  10. CBER INFORMATION

| MATES June 15th Meeting Agenda |