Posted by Michael Wonder on 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that incorporate genome editing of human somatic cells and chimeric antigen receptor T cell products.
In the draft guidance on human gene therapy products that incorporate human genome editing, FDA offers recommendations on the information that should be included in an investigational new drug application.
The draft guidance, issued on 15 March by FDA’s Center for Biologics Evaluation and Research, provides information on component design, component manufacture and testing, product manufacture and testing, and preclinical and clinical studies.
