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

• Date: November 04, 2009
• Source: www.fda.gov

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; AvailabilityThe 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 The guidance  announced in this notice finalizes the  draft guidance of the same title, dated  May 2008.


 

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