Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage: Guidance for Industry
https://www.fda.gov/media/82562/download
Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry
https://www.fda.gov/media/87564/download
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
Human Gene Therapy for Retinal Disorders: Guidance for Industry
https://www.fda.gov/media/124641/download
Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry
https://www.fda.gov/media/72402/download
EMA Eudralex Volume 4 Annex 1 – EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf