FDA Webinar Resources
- OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn)
FDA Guidances
Websites
- Information on Submitting an Investigational New Drug Application for a Biological Product
- CBER Guidance, Compliance and Regulatory Information (Biologics)
Gene Therapy Guidances
- Draft Guidance for Industry: Chemisty, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), July 2018
- Draft Guidance for Industry: Long Term Follow-up After Administration of Human Gene Therapy Products, July 2018
- Draft Guidance for Industry: Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacturing and Patient Follow-up, July 2018
- Draft Guidance for Industry: Human Gene Therapy for Hemophilia, July 2018
- Draft Guidance for Industry: Human Gene Therapy for Rare Diseases, July 2018
- Draft Guidance for Industry: Human Gene Therapy for Retinal Disorders, July 2018
Guidance Documents
- Draft Guidance for Industry: Rare Diseases: Common Issues in Drug Development, Jan 2019
- 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- Draft Guidance for Industry: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, Nov 2017
- Draft Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, Nov 2017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
- Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, Nov 2013
- Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products, June 2015
- Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, Jan 2011
- Guidance for Industry: Cellular Therapy for Cardiac Disease, Oct 2010
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs), April 2008
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), April 2008
- Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Aug 2007
- HHS-FDA Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishment; Inspection and Enforcement; Final Rule, Nov 2004
- Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, Sept 2004
- 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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