FDA Releases Guidance on Minimally Manipulated Placental/Umbilical Cord Blood for Hematopoietic Reconstitution

Summary

The Food and Drug Administration (FDA) has published a guidance document outlining recommendations for manufacturers seeking licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood for hematopoietic reconstitution in specified indications, as part of its efforts to regulate the use of these products for hematopoietic progenitor cells, cord (HPC-C).