Biologics License Application (BLA)

A Biologics License Application (BLA) is a formal request submitted to the U.S. Food and Drug Administration (FDA) seeking authorization to market a biologic product in the United States. Biologics are products derived from living organisms, including vaccines, blood components, and gene therapies. The BLA process involves a comprehensive review of clinical data, manufacturing practices, and labeling to ensure the safety, efficacy, and quality of the biologic. The application includes detailed information on the product’s development, testing results, and proposed use. Once approved, the BLA grants the applicant permission to introduce the biologic into interstate commerce, enabling its distribution and use in medical treatments across the country. The FDA’s rigorous evaluation ensures that biologics meet high standards of safety and effectiveness.