Biologic License Application

What is a biologic license application (BLA)? The biologic license application (BLA) is a document required by the FDA to allow the transport of biologics across state lines and get approval for clinical use. The BLA is usually submitted after IND submission, and the appropriate clinical testing has taken place. Regulation of biological products is generally managed by the Center for Biologics Evaluation and Research (CBER). The response time from the FDA receiving the application is 75 days.

Requirements of the BLA

The BLA is meant to assure that the product is “safe, pure, and potent.” The requirements specified by Form 365h include:

  • Applicant information 
  • Marketing and product information, including chemistry, manufacturing, and controls.
  • Pre-clinical data
  • Data from clinical studies
  • Labeling

Source: Center for Biologics Evaluation and Research. (2021, January 27). Biologics License Applications (BLA) Process (CBER). U.S. Food and Drug Administration. Retrieved August 22, 2022, from https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber#:%7E:text=The%20Biologics%20License%20Application%20(BLA,under%2021%20CFR%20600%20%E2%80%93%20680.