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.

摘要

The Center for Biologics Evaluation and Research (CBER), FDA, are providing advice to potential sponsors (e.g., cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators) to assist in the submission of an Investigational New Drug Application (IND) for certain hematopoietic progenitor cells, cord (HPC-C), when such HPC-Cs are not licensed in accordance with Title 21 Code of Federal Regulations Part 601 (21 CFR Part 601), 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 available. If unlicensed HPC-Cs are made available for clinical use, they must be distributed under an IND meeting the applicable requirements in 21 CFR Part 312. This guidance finalizes the draft guidance entitled 'Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical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' dated October 2009 (October 20, 2009, 74 FR 53751) (draft IND guidance).