Glossary Term
Biologics License Application (BLA)
Definition
A Biologics License Application (BLA) is a formal submission to the U.S. Food and Drug Administration (FDA) requesting approval to market a biologic product. Biologics include complex products derived from living organisms, such as vaccines, blood products, gene therapies, and monoclonal antibodies. The BLA includes comprehensive data demonstrating the product’s safety, purity, and potency.
Relevance to the MedTech Industry
The BLA ensures that biologic products meet rigorous regulatory standards before entering the market. By reviewing preclinical, clinical, manufacturing, and quality data, the FDA ensures that biologics are safe, effective, and consistent, protecting patient health and fostering public trust in these innovative therapies.
Additional Information & Related Terms
Investigational New Drug (IND) Application Precedes the BLA and permits clinical testing of a biologic.
Good Manufacturing Practices (GMP) Governs the production standards for biologics under a BLA.
Post-Market Surveillance Ensures the ongoing safety and efficacy of biologics after approval.
Risk Evaluation and Mitigation Strategies (REMS) May be required for biologics with known risks.