FDA Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications
https://www.fda.gov/media/78428/download
Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry
https://www.fda.gov/media/82312/download
Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry
https://www.fda.gov/media/87564/download
Cellular Therapy for Cardiac Disease: Guidance for Industry
https://www.fda.gov/media/76587/download
Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry
https://www.fda.gov/media/77497/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
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for Industry
https://www.fda.gov/media/120267/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