Draft Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft document 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," dated October 2009. In this draft guidance, we refer to these products for hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C). This draft guidance provides advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor- investigators) to assist in the submission of an IND for certain HPC- Cs, when such HPC-Cs are not licensed in accordance with certain FDA regulations, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment. This draft guidance document is applicable only to HPC-Cs intended for hematopoietic reconstitution in patients with the clinical indications listed in the gui