Biologic License Application

A Biologic License Application (BLA) is a formal request submitted to a regulatory agency like the FDA to get approval to market a biologic product, such as vaccines, blood products, or cell therapies. It includes extensive scientific data demonstrating that the product is safe, effective, and of quality. The goal is to ensure that the biologic meets rigorous standards before it becomes available to patients. Once approved, the BLA grants legal permission to manufacture and sell the biologic in the marketplace.