REGULATORY UPDATE: AABB Releases BLA Checklist for Plasma Collected by Apheresis

AABB is pleased to announce the availability of a new toolkit, BLA Checklist for Plasma Collected by Apheresis, to assist AABB members in the development of a submission to the Food and Drug Administration in support of an initial blood license application (BLA) or a submission of changes to an approved BLA for plasma collected by apheresis.

The toolkit, developed by the AABB Regulatory Affairs Committee, contains a comprehensive checklist of items necessary in consideration of a BLA submission or prior approval supplement, including the use of comparability protocols under 21 CFR 601.12(e) and labeling changes under 21 CFR 601.12(f).   

In addition to the new BLA Checklist for Apheresis Plasma, AABB’s Regulatory Toolkits web page includes A BLA Checklist for Platelets, Leukocytes Reduced, Collected by Apheresis and a BLA Checklist for RBCs Collected by Apheresis.

AABB encourages members to visit the Regulatory Toolkits web page frequently to review additional toolkits available to help guide them through the regulatory decision-making process. Questions may be sent to regulatory@aabb.org.