Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for Industry
https://www.fda.gov/media/89036/download
Non classé
Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products
https://www.ema.europa.eu/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
Human Gene Therapy for Hemophilia: Guidance for Industry
https://www.fda.gov/media/113799/download
Cellular Therapy for Cardiac Disease: Guidance for Industry
https://www.fda.gov/media/76587/download
Human Gene Therapy for Rare Diseases: Guidance for Industry
https://www.fda.gov/media/113807/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
Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry
https://www.fda.gov/media/72402/download
Human Gene Therapy for Retinal Disorders: Guidance for Industry
https://www.fda.gov/media/124641/download