ISSCR News
ISSCR Members Hold First Scientific Advice Meeting with the U.K.’s Medicines and Healthcare products Regulatory Agency
The International Society for Stem Cell Research (ISSCR) held its first Broader Scope Scientific Advice meeting with the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on May 15, 2023. ISSCR’s regulatory advocacy aims to give its members a voice to help educate policymakers about scientific findings and considerations that will help regulators make scientifically informed policy decisions and facilitate the development of advanced stem cell-based therapies and applications.
The ISSCR Provides Comments on FDA’s Draft Guidance for Potency Assurance for Cellular and Gene Therapy Products
On 5 March 2023, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Potency Assurance for Cellular and Gene Therapy (CGT) Products.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.
The ISSCR Provides Comments on FNIH’s Accelerating Medicines Partnership Cell-Based Therapy Initiative
On 25 September 2023, the ISSCR submitted comments in response to the Foundation for National Institutes of Health’s (FNIH) Request for Information on Cell-Based Therapies for use in developing an Accelerating Medicines Partnership (AMP) Cell-Based Therapy Consortium.
ISSCR Offers Recommendations on Risk Mitigation in Advancing Stem Cell Therapies
On 13 December 2022, ISSCR hosted its annual Liaison Meeting with the U.S. Food and Drug Administration. FDA professionals gathered virtually with ISSCR leaders to discuss advances in the development of stem cell therapies.
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