Biologics License Application

A Biologics License Application (BLA) is a formal request submitted to the U.S. Food and Drug Administration (FDA) by a company seeking approval to market a biological product, such as vaccines, blood products, or gene therapies. The application includes detailed information about the product’s safety, effectiveness, manufacturing processes, and proposed labeling. The FDA reviews the BLA to ensure that the product meets the necessary standards for quality and public health before it can be sold to consumers. Essentially, it’s a crucial step in ensuring that biologics are safe and effective for public use.