Enter to open, tab to navigate, enter to select
Biologics License Application (BLA)
Practical Law Glossary Item w-001-4084 (Approx. 3 pages)
Glossary
Biologics License Application (BLA)
A federal application for a license to market a biological product in the US under Section 351 of the Public Health Service Act (42 U.S.C. § 262). A biological product is a protein, vaccine, another type of therapeutic agent listed in the statute, or an analogous product. Biological products may be produced from natural sources or through biotechnology (42 U.S.C. § 262(i)(1)).
A biologics license application (BLA) must include sufficient information and data for the Food and Drug Administration (FDA) to determine that the biological product is safe and effective for its proposed indications. A BLA typically includes:
- Data from nonclinical, laboratory, and clinical studies that demonstrate that the biologic meets prescribed requirements of safety, purity, and potency.
- A full description of the methods used to manufacture and package the biologic and information concerning each facility involved.
- Samples of the proposed product labeling, enclosures, and containers, including any package insert or prescribing information.