Regulatory Focus™ > News Articles > Quality & Compliance: FDA Streamlines Licensure Approach for Certain Cord Blood Products

Quality & Compliance: FDA Streamlines Licensure Approach for Certain Cord Blood Products

Posted 01 April 2010 | By

Minimally manipulated, unrelated allogeneic placental/umbilical cord blood is well recognized as a source of hematopoietic stem/progenitor cells for transplantation in patients with life-threatening conditions such as leukemia, bone marrow failure and primary immunodeficiency diseases. Patients in need of cord blood transplantation can find suitably matched products through national and international registries. The US Food and Drug Administration (FDA) has now developed an approach to licensure of these products that will allow cord blood manufacturers to apply for a Biologics License Application (BLA) using a streamlined approach. This licensure approach was developed in conjunction with the riskbased regulations (21 CFR Part 1271) for human cells and tissue. Until recently, FDA exercised enforcement discretion and delayed implementation of BLAs and Investigational New Drug Applications (IND) for these cell products. This article explains this new licensure process as well as what INDs are now required for other cord blood products not qualified for streamlined BLA approval.

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