What Does BLA Stand For?

BLA stands for Biologics License Application CBER

The Biologics License Application (BLA) is a submission to the Center for Biologics Evaluation and Research (CBER) within the U.S. Food and Drug Administration (FDA). It is required for the approval of biologic products, including vaccines, blood components, and gene therapies. The BLA provides comprehensive data regarding the product's safety, effectiveness, manufacturing processes, and labeling, enabling CBER to assess and determine whether the biologic can be marketed to the public.