Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
https://www.fda.gov/media/91425/download
Non classé
ICH considerations : General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors
https://admin.ich.org/sites/default/files/2019-04/ICH_Considerations_General_Principles_Risk_of_IGI_GT_Vectors.pdf
ICH considerations : General Principles to Address Virus and Vector Shedding
https://admin.ich.org/sites/default/files/2019-04/ICH_Considerations_Viral-Vector_Shedding_.pdf
Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs
https://www.ema.europa.eu/en/documents/other/questions-answers-principles-gmp-manufacturing-starting-materials-biological-origin-used-transfer_en.pdf
Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry
https://www.fda.gov/media/82312/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
Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry
https://www.fda.gov/media/87564/download
Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage: Guidance for Industry
https://www.fda.gov/media/82562/download