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 Advocates for Stem Cell Research on Capitol Hill
On a beautiful spring day in Washington, D.C., leaders from the ISSCR walked the halls of the U.S. Congress to inform legislators and their health policy staff about the progress and potential of stem cell research during the annual ISSCR Congressional Advocacy Day.
The ISSCR Provides Comments on FDA’s Draft Guidance for Potency Assurance for Cellular and Gene Therapy Products
On 5 March 2023, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Potency Assurance for Cellular and Gene Therapy (CGT) Products.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 Signs On to the Coalition for Health Funding’s Non-Defense Discretionary (NDD) United Campaign
On 3 January 2024, the ISSCR signed on to the NDD United campaign urging Congress to complete the FY 2024 appropriations process and adopt the bipartisan Senate funding framework as a starting point for final negotiations.
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