Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products" dated September 2009. The guidance document provides 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. The guidance identifies 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). The guidance announced in this notice finalizes the draft guidance of the same title, dated May 2008.