FDA Announces Guidance for Industry on Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood

Summary

The Food and Drug Administration (FDA) has released a guidance document providing advice to potential sponsors on submitting Investigational New Drug Applications (INDs) for certain types of hematopoietic stem/progenitor cells derived from placental/umbilical cord blood, intended for use in patients with specific medical conditions where a suitable alternative treatment is not available.