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Biologics License Applications

Overview

A Biologics License Application (BLA) is submitted by a blood establishment (or other licensed establishment) to the Food and Drug Administration (FDA) for approval prior to distributing blood and blood components (or other biologic products) in interstate commerce, as required in 21 CFR 601.2. The BLA regulations are found in 21 CFR 600 to 680. The BLA requests FDA approval and licensure for an establishment to collect and manufacture a blood product, or combination of products, using standard operating procedures that are incompliance with product and establishment standards.  A license supplement to an approved BLA is required by FDA when changes are made to the establishment’s manufacturing processes in the approved BLA. FDA’s Form 356h specifies the requirements for a BLA.

Among other responsibilities, the AABB Regulatory Affairs Committee (RAC) assists the AABB membership by updating checklists to assist blood establishments in meeting the submission requirements of a BLA and license supplement. The RAC creates checklists as new products receive FDA approval. Currently, checklists provide detailed information for preparation of submissions for platelets, red blood cells and plasma. In February 2017, the AABB RAC began a comprehensive review process to ensure checklists are consistent with current FDA regulations and guidance recommendations.

AABB works directly with government agencies, including FDA, by submitting comments to the docket, as part of the rulemaking process, in response to recommendations issued in guidance documents, and by providing reviews of regulatory issues concerning the requirements of the BLA and IND application processes.

In October 2011, the FDA extended BLA requirements to certain cellular therapy products. Refer to the AABB webpage, Cellular Therapies, for a comprehensive information and a wide range of resources regarding cellular therapy products, including information on the BLA.