Zdrowie i gospodarka · 17/06/2013

FDA Releases Draft Guidance for Cord Blood Applications

The FDA has released a draft document outlining recommendations for manufacturers to apply for licensure of minimally manipulated, unrelated allogeneic cord blood for hematopoietic and immunologic reconstitution in patients with hematopoietic disorders, with the goal of assisting manufacturers in obtaining a biologics license.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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