Biologics License Application (BLA)

A Biologics License Application (BLA) is a formal request submitted to the U.S. Food and Drug Administration (FDA) seeking approval to market a biological product, such as vaccines, gene therapies, or cell-based treatments. It includes detailed data from research and clinical trials showing the product's safety, effectiveness, and manufacturing quality. The FDA reviews this information to determine whether the product is safe and effective for public use. Once approved, the product can be legally marketed and sold in the United States. The BLA process ensures that biological medicines meet strict standards before reaching patients.