FDA Releases Draft Guidance for IND Applications of Minimally Manipulated Cord Blood

Summary

The Food and Drug Administration (FDA) has released a draft guidance document outlining the process for submitting Investigational New Drug Applications (INDs) for minimally manipulated, unrelated allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution for specified indications. The guidance is aimed at assisting potential sponsors in submitting INDs for certain cord blood products that are not yet licensed under FDA regulations.