FDA Webinar Resources
- (Office of Tissues and Advanced Therapies; previously OCTGT Learn)
FDA Guidances
Websites
Gene Therapy Guidances
Guidance Documents
- Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception, Nov 2017
- Guidance for Industry: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, Nov 2017
- Draft Guidance for Industry: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, Nov 2017
- Draft Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, Nov 2017
- Guidance for Industry: Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, Nov 2017
- HHS-FDA Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule, Feb 2004
- Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy, March 1998
FDA Presentations
- Preclinical Considerations for Stem Cell-Based Products, Mercedes Serabian-FDA, Nov 2009
- CMC Considerations for Stem Cell-based Products, Don Fink-FDA, Nov 2009
- The Biologics License Application (BLA), Diane Hall-FDA, Sept. 2009
- An Introduction to FDA’s Clinical Trial Review, Ke Liu-FDA, July 2007
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