This guidance provides recommendations to you, manufacturers, sponsors, and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus. We, FDA, are issuing this guidance to assist you by identifying data and information obtained during investigational new drug (IND) studies that might be helpful in establishing the safety, purity, and potency of a biological product. This guidance is not intended to identify all of the product, preclinical, and clinical data that might be needed to successfully support a biologics license application (BLA). This guidance finalizes the draft guidance of the same title, dated May 2008.

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