Recommendations for cord blood banks and individual physicians serving as sponsor-investigators to assist in the submission of an investigational new drug (IND) application for hematopoietic progenitor cells, cord (HPCC) that are not licensed for use were provided by the FDA in a draft guidance. Titled “Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,the draft document is applicable only to HPCCs used for hematopoietic reconstitution in patients with clinical indications listed in a companion guidance (¶320,367). The submissions procedures should be used, specifically, for HPCCs that are manufactured: (1) in non-United States cord blood establishments, listed in international cord blood registries, and selected for treatment of a patient in the U.S.; (2) in U.S. cord blood establishments before a biologics license application has been approved and not shown to meet licensing criteria; or (3) prospectively in the U.S. and do not meet licensing criteria, but for which there is no satisfactory alternative.
SOURCE: FDA Notice
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