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. 2004;40(3 Suppl):19-22.
doi: 10.1385/cbb:40:3:19.

FDA regulation of allogeneic islets as a biological product

Darin J Weber  1
Affiliations

FDA regulation of allogeneic islets as a biological product

Darin J Weber. Cell Biochem Biophys. 2004.

Abstract

This article describes the Food and Drug Administration's recent manufacturing review experience with investigational new drug applications submitted for allogeneic pancreatic islets of Langerhans for the treatment of type 1 diabetes mellitus. In addition, considerations of islet preparation issues that will need to be resolved before the submission of a biologics license application are discussed.

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