New Drug Application
/ˌnjuː ˈdrʌɡ æplɪˈkeɪʃən/
Definitions
- (n.) A formal proposal submitted to a regulatory authority seeking approval to market a new pharmaceutical drug.
The pharmaceutical company filed a new drug application with the FDA to obtain marketing authorization.
Forms
- new drug application
- new drug applications
Related terms
See also
Commentary
In drafting, be precise about jurisdiction and regulatory body to clarify procedural requirements.
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.