FDA Releases Draft Guidance for Industry on Investigational New Drug Applications for Cord Blood

Summary

The Food and Drug Administration (FDA) has released a draft guidance document to help industry sponsors, such as cord blood banks and transplant centers, prepare Investigational New Drug Applications for minimally manipulated, unrelated allogeneic placental/umbilical cord blood intended for hematopoietic and immunologic reconstitution in patients with hematopoietic disorders.