Regulatory Deadline Board/2026-19563

Food and Drug Administration · Notice

Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information

11 days left

In plain English

HHS is asking how deceased-donor islet cells for Type 1 diabetes should be regulated, including whether unmodified isolates should be treated differently from modified products.

Who it hits

Cell therapy sponsors, transplant programs, diabetes clinics, and islet processing labs.

Agency
Food and Drug Administration
Document type
Notice
Published
Sep 24, 2026
Comments close
Nov 9, 2026
Status
11 days left
Federal Register number
2026-19563
Docket
Docket No. FDA-2026-N-10738

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