New Drug
/ˈnuː ˌdrʌɡ/
Definitions
- (n.) A substance not previously approved for medical use and subject to regulatory evaluation before market authorization.
The pharmaceutical company submitted clinical data to obtain approval for the new drug.
Forms
- new drug
Related terms
See also
Commentary
In legal contexts, "new drug" frequently entails regulatory significance under statutes like the Federal Food, Drug, and Cosmetic Act, emphasizing the need to distinguish from previously approved substances.
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.