FDA Releases Draft Guidance for Minimally Manipulated Cord Blood for Hematological Malignancies

Summary

The FDA has made available a draft document outlining recommendations for the licensure of minimally manipulated, unrelated, allogeneic cord blood for hematopoietic reconstitution in patients with hematological malignancies, with the goal of providing a clearer pathway for manufacturers to bring this life-saving treatment to market.