Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications," dated October 2009. In this guidance, we refer to these products for hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C). This guidance (HPC-C licensure guidance) provides recommendations to manufacturers applying for licensure of minimally manipulated, unrelated allogeneic placental/ umbilical cord blood, for specified indications. Elsewhere in this issue of the Federal Register, FDA is publishing a draft guidance entitled "Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications." FDA is also announcing the end of the phased-in implementation period for IND and biologics license application (BLA) requirements for minimally manipulated unrelated allogeneic hematopoietic stem/progenitor cell produ