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Biologics License Application (BLA)

What is a biologics license application (BLA)?

A BLA is a request for permission to introduce (or deliver for introduction) a biologic product. The U.S. Food and Drug Administration (FDA) reviews all BLAs, and all introduced biologics are regulated under 21 CFR 600 – 680.

Any legal person or entity engaged in the manufacturing of a biologic product or anyone applying for a license and taking responsibility for compliance with product and establishment standards must submit a BLA. With a BLA, the biologic can be distributed across states.

The BLA must include:

  • Applicant information
  • Product and/or manufacturing information
  • Labeling
  • Pre-clinical studies
  • Clinical studies

The BLA is generally submitted after an investigational new drug (IND) or an investigational device exemption (IDE), and after the appropriate studies have been completed.

How does a BLA improve healthcare?

The BLA ensures that vaccines, blood products, genetic and cellular therapies, and other allogenic drug products meet federal regulatory standards. This is vital for ensuring that patients are given safe and effective treatments and therapies. Furthermore, having this level of regulation helps to increase patient trust in the therapies that can help them.