FDA regulation of allogeneic islets as a biological product.
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.
US 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
Darin J
DJ
Weber
D001686:Biological Phenomena; D001688:Biological Products / Q000378:metabolism; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D006152:Cyclic GMP / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000628:therapy*; D017277:Drug Approval; D006801:Humans; D017387:Investigational New Drug Application; D007515:Islets of Langerhans / Q000473:pathology; D016381:Islets of Langerhans Transplantation / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products; D006152:Cyclic GMP