- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, the Center for Biologics Evaluation and Research (CBER), FDA, are recommending ways that would allow you, the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. This guidance document is intended to assist you in obtaining a biologics license. It contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2006-D-0157.