Biologics License Application
/ˌbaɪəˈlɒdʒɪks ˈlaɪsəns ˌæplɪˈkeɪʃən/
Definitions
- (n.) A formal request submitted to the FDA for approval to market a biologic product in the United States, containing data on its safety, purity, and potency.
The pharmaceutical company filed a biologics license application to obtain marketing approval for the new vaccine.
Forms
- biologics license application
- biologics license applications
Related terms
See also
Commentary
The term is strictly regulatory and used chiefly in U.S. federal law governing biologic medical products.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.