Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products, intended to provide recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of Type 1 diabetes mellitus. It intends to identify the types of data and information obtained during investigational new drug studies that may be helpful in establishing the safety, purity, and potency of a biological product in a biologics license application (BLA). To download this guidance, click here. To view this notice, click here.