On 29 July 2024, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.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.

On 10 April 2024, the ISSCR held its first Academia Briefing Meeting with the European Medicines Agency (EMA). The meeting was organized by ISSCR’s Manufacturing, Clinical Translation, and Regulatory (MCTR) Committee and included invitees to present to the agency on two topics: recommendations for the manufacturing of PSC banks as starting materials for allogeneic PSC-based therapies and genetic characterization of human PSCs. Following the meeting, both parties confirmed the importance of regular meetings to ensure a bi-directional sharing of knowledge to advance the development of cellular therapies.