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Sustained Administration of β-cell Mitogens to Intact Mouse Islets Ex Vivo Using Biodegradable Poly(lactic-co-glycolic acid) Microspheres
Published on: November 5, 2016
FDA regulation of allogeneic islets as a biological product
1US Food and Drug Administration, Center for Biologics Evaluation and Research, Offices of Cells, Tissue and Gene Therapies, Division of Cellular and Gene Therapies, Rockville, MD, USA. dweber@bcg-usa.com
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.

