Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors
https://www.fda.gov/media/73624/download
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry
https://www.fda.gov/media/73072/download
Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry
https://www.fda.gov/media/79856/download
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry
https://www.fda.gov/media/113760/download
Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception
https://www.fda.gov/media/89920/download
Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry
https://www.fda.gov/media/77497/download
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for Industry
https://www.fda.gov/media/120267/download
Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry
https://www.fda.gov/media/113768/download