Issue Date: March 1, 2014
Issued by: Center for Biologics Evaluation and Research
Topic(s): Cellular & Gene Therapy, Gene Therapy
Status: Final
BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry
We, the Center for Biologics Evaluation and Research (CBER), FDA, are recommending ways that would allow you, the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. This guidance document is intended to assist you in obtaining a biologics license. It contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements.
Download the Guidance Document
