FDA Announces Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood

Summary

The Food and Drug Administration (FDA) has released a document providing recommendations for manufacturers of cord blood banks on how to apply for a biologics license for minimally manipulated, unrelated allogeneic placental/umbilical cord blood intended for patients with hematopoietic disorders, following a finalization of the draft guidance in June 2013 and superseding a previous guidance from 2013.