ISSCR News
The ISSCR Signs on to Coalition Letter in Support of NIH
The ISSCR joined with Research!America, hundreds of biomedical research organizations, and thousands of private citizens from the U.S. scientific community to urge House and Senate appropriators to avoid a full-year continuing resolution for Fiscal Year 2025 appropriations and instead provide a robust funding increase for the National Institutes of Health (NIH). The letter also calls for the preservation of existing protections against cuts to reimbursement for NIH grantee Facilities and Administrative costs. These drastic cuts will slow scientific progress and weaken the U.S. research ecosystem.
The ISSCR Encourages Japanese Policymakers to Increase Oversight of Regenerative Medicine Interventions
Today, the ISSCR sent a letter to Japan’s Ministry of Health, Labour, and Welfare encouraging the Ministry to implement regulations that adhere as closely as possible to international guidelines for the administration of regenerative medicine interventions.
In the letter, shared in response to amendments to the Act on the Safety of Regenerative Medicine (ASRM), the ISSCR commends Japan for taking steps to strengthen the ASRM to protect patient safety and offers recommendations citing this opportunity to strengthen Japan’s approach to regenerative medicine oversight.
Ninth Circuit Reverses Lower Court, Reinforces FDA’s Authority to Regulate Unproven Stem Cell Products
In an important step to protect the public from unproven stem cell products, the U.S. Court of Appeals for the Ninth Circuit ruled in favor of the U.S. Food and Drug Administration in U.S. v. California Stem Cell Treatment Center, Inc., reversing the district court. The reversal fortifies FDA’s tiered, risk-based framework for the regulation of cell therapies and is consistent with a similar ruling in the Eleventh Circuit in 2021.
Applications Open for ISSCR Lawrence Goldstein Science Policy Fellowship
The ISSCR is accepting applications through 25 October 2024 for the next class of Lawrence Goldstein Science Policy Fellows. The three-year program offers fellows advocacy and public policy training, the opportunity to participate in ISSCR advocacy events, engagement with leaders in the field, and an ex officio seat on ISSCR’s Public Policy Committee.
The ISSCR Responds to FDA’s Draft Guidance on Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products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.
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