What is the purpose of a BLA?

• A. To approve a chemical drug
• B. To license a device
• C. To seek approval for a biologic product in the US
• D. To license a vaccine

Answer: (C)

A Biologics License Application (BLA) is the FDA submission used to obtain marketing authorization for biologic products in the United States. Biologics include vaccines, therapeutic proteins, monoclonal antibodies, cell and gene therapies, and other products made from living organisms. The BLA bundles clinical data on safety and efficacy with chemistry, manufacturing, and controls information that describes how the product is made, analyzed, and quality-controlled, along with labeling and post-approval plans. This pathway is distinct from the NDA used for chemical drugs and from device submissions (such as 510(k) or PMA). Therefore, the purpose of a BLA is to seek approval for a biologic product in the US, which includes vaccines.