Biological License Application (BLA)

A Biological License Application (BLA) is a request submitted to the U.S. Food and Drug Administration (FDA) for permission to sell a biological product, such as vaccines or blood components. The application contains detailed information about the product's ingredients, how it is made, its effectiveness, and safety. The FDA reviews the BLA to ensure that the product meets regulatory standards for quality and effectiveness before it can be marketed to the public, ultimately aiming to protect public health.