ISSCR News
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.
The ISSCR Files Amicus Brief Supporting FDA’s Authority to Regulate Unproven Stem Cell-Based Interventions
The International Society for Stem Cell Research (ISSCR) filed an amicus curiae brief today to support the U.S. government’s appeal in U.S. v. California Stem Cell Treatment Center, Inc., a case that ruled the Food and Drug Administration (FDA) cannot regulate dangerous unproven stem cell-based interventions.
ISSCR Shares Concerns Regarding New Google Ads Policy
…the ISSCR is concerned that unscrupulous clinics may misuse the update to Google’s policy by promoting unproven therapies under the guise of distributing material that is “exclusively educational or informational in nature.” If so, this would harm consumers and public health.
The ISSCR Comments on Draft Guidance from FDA - Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
The ISSCR shared comments on draft guidance from the FDA's Center for Biologics Evaluation and Research (CBER) (Docket No. FDA2021-D-1146) Real-World Data: Assessing Registries to Support Regulatory Decision Making for Drug and Biological Products.
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