Considerations for Allogenic Pancreatic Islet Cell Products

Guidance for Industry

Cell & Gene, FDA Guidelines, Pancreatic Islet Cells

FDA guidance for recommendations on clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-allogeneic-pancreatic-islet-cell-products

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U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research

Published June 2015

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