BLA (Biologics License Application)

A Biologics License Application (BLA) is a request submitted to the U.S. Food and Drug Administration (FDA) for approval to market a biological product, such as vaccines, blood products, or gene therapies. This application includes detailed information about the product's safety, effectiveness, manufacturing processes, and labeling. A BLA ensures that the product meets strict regulatory standards before it can be made available to the public, helping to protect patient health and ensure quality in biologic therapies.