Biologic license application (BLA)

A Biologic License Application (BLA) is a request submitted to the U.S. Food and Drug Administration (FDA) for permission to market a biologic product, which is derived from living organisms, like vaccines or gene therapies. The application includes detailed information about the product's manufacturing, safety, and effectiveness. Once approved, the BLA allows companies to sell their biologic products, ensuring they meet necessary health standards and regulatory requirements. This process helps ensure that biologics are safe and effective for patients.