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Product safetyFDAUnited StatesImports

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

24 September 2026

In plain English

HHS is opening a public docket seeking information and comments on how to regulate deceased donor islet cells and islet cell products used to treat Type 1 diabetes.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
24 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Department of Health and Human Services (HHS) is opening a public docket to solicit input, supporting data, and comments to assist HHS as it considers how best to regulate deceased donor islet cells and/or deceased donor islet cell products for the treatment of Type 1 diabetes (T1D). The purpose of this information is to allow HHS agencies to better understand how best to regulate these therapies, including whether and how regulation could differ between isolated and otherwise unmodified
The full text is at the source

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