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Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
This guidance document provides recommendations for the submission of a biologics license application (BLA) (21 CFR Part 601) for placental/umbilical cord blood products that are: manipulated minimally; and intended for hematopoietic reconstitution in patients with hematological malignancies; and intended to be used in recipients unrelated to the donor.

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