The ISSCR Provides Comments on FDA’s Draft Guidance for Potency Assurance for Cellular and Gene Therapy Products
On 5 March 2023, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Potency Assurance for Cellular and Gene Therapy (CGT) Products. ISSCR appreciates FDA’s commitment to assuring the potency of human CGT products at all stages of the product lifecycle. This guidance from the FDA will help our members, who are at the forefront of research and innovation, in their work.
ISSCR’s comments request FDA to offer additional guidance on retrospective testing and to share their perspective on the in vivo performance of cell therapies. We believe that these comments and suggestions can help enhance FDA’s initiatives and contribute to advancing the field.