ISSCR News
The ISSCR Comments on Draft Guidance from FDA - Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
The ISSCR shared comments on draft guidance from the FDA's Center for Biologics Evaluation and Research (CBER) (Docket No. FDA2021-D-1146) Real-World Data: Assessing Registries to Support Regulatory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.
The ISSCR Launches Standards Initiative for Pluripotent Stem Cell Research
Universally accepted characterization standards for stem cell research are needed to improve the rigor and reproducibility of stem cell research. Standards set researchers up for success, ensure rigor in preclinical research, and ultimately strengthen the pipeline of therapies for patients. As the foremost international stem cell research society with a reputation for scientific and ethical rigor, the ISSCR is uniquely positioned to develop and propose research standards that can be widely adopted worldwide.
Advocating for Regulations that Facilitate Safe and Efficacious Therapies
Last December, nearly 40 professionals with the U.S. Food and Drug Administration (FDA) gathered with ISSCR leaders to discuss advances in the development of stem cell therapies. The attendance of FDA leaders – Peter Marks, Director, Center for Biologics Evaluation and Research (CBER), Celia Witten, Deputy Director, CBER, and Wilson Bryan, Director, Office of Tissues and Advanced Therapies (OTAT) – signals how important it is for the agency to discuss scientifically informed recommendations from the ISSCR as new stem cell-based therapies advance.
The ISSCR Comments on the MHRA Consultation on Point of Care Manufacturing
The ISSCR submitted comments to the UK's MHRA on the Consultation on Point of Care Manufacturing that state, among other key points…
The ISSCR submitted comments on the CY 2022 Medicare OPPS and APC Proposed Rule
The ISSCR submitted comments on the CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1753-P).
Receive ISSCR Press Releases
Sign up be a part of ISSCR’s media list. Media Contact: Kym Kilbourne, Director of Media and Strategic Communications
Subscribe to ISSCR News.
Each month, ISSCR delivers scientific, policy, and community to your inbox .