The ISSCR Responds to FDA’s Draft Guidance on Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
On 29 July 2024, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. ISSCR supports FDA’s desire to share their recommendations for determining the appropriate cell safety testing and offers comments to complement FDA's initiative. Specifically, ISSCR requests clarification on genomic testing requirements and proposes adjustments to the guidance on sequencing depth and cytogenetic testing. Additionally, ISSCR recommends using both sequencing and cytogenetic testing to ensure comprehensive safety assessments.