WASHINGTON, Sept. 23 -- The U.S. Department of Health & Human Services issued the following press release:
The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), today released a Request for Information (RFI), "Improving Patient Access to Deceased Donor Islet Cells and Cell Products," seeking public input on how the federal government should regulate certain deceased donor islet cells and cell products used to treat type 1 diabetes. The RFI asks whether the current FDA-led biological product framework creates barriers to patient access and whether an alternative transplant-based framework could improve access while maintaining rigorous safety and quality protections.
Under the current ...