ISSCR News
ISSCR Holds First Academia Briefing Meeting with the European Medicines Agency
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.
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The ISSCR Provides Comments on FDA’s Draft Guidance for Potency Assurance for Cellular and Gene Therapy Products
On 5 March 2023, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Potency Assurance for Cellular and Gene Therapy (CGT) Products.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.
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