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FDA Human Gene Therapy Products Incorporating Human Genome Editing  (Catapult’s regulatory round-up – february 2024)

In recent years, human genome editing (GE) as a scientific technology used in the treatment of human disease has substantially increased, and there has been rapid development of gene therapy products incorporating GE. To assist in the translation of these products to clinical trials, the FDA has issued a final guidance which provides recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. It provides recommendations regarding information that should be provided in an Investigational New Drug (IND) application in order to assess the safety and quality of the investigational GE product, as required in Title 21 of the Code of Federal Regulations 312.23 (21 CFR 312.23) and includes information on product design, product manufacturing and testing, non-clinical safety assessment, as well as clinical trial design.

Published on the 5th of March 2024 in Catapult’s regulatory round-up for february 2024.

 


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Human Gene Therapy Products Incorporating Human Genome Editing  (Catapult’s regulatory round-up – february 2024). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/12mib


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