Public consultation on Human Gene Therapy Products incorporating Human Genome Editing Food and Drug Administration (FDA) (Cell and Gene Therapy Catapult – Regulatory Round-up – April 2022)
The FDA held a public consultation from March 2022 until the 14th of July 2022 on Human Gene Therapy Products incorporating Human Genome Editing, the draft guidance document can be found here.
In this guidance, the FDA is providing recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, this guidance 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).
This includes information on product design, product manufacturing, product testing, preclinical safety assessment, and clinical trial design.
See all of Catapult’s Regulatory Round-up for April 2022 here. Published on the 29th of April 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (3 août 2022). Public consultation on Human Gene Therapy Products incorporating Human Genome Editing Food and Drug Administration (FDA) (Cell and Gene Therapy Catapult – Regulatory Round-up – April 2022). ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/o61w





