Investigational New Drug
/ˌɪnˌvɛstəˈɡeɪʃənəl nuː drʌɡ/
Definitions
- (n.) A drug that has not yet been approved by regulatory authorities for general use and is allowed to be used only in clinical trials for safety and efficacy evaluation.
The pharmaceutical company submitted an investigational new drug application to begin human trials.
Forms
- investigational new drug
- investigational new drugs
Related terms
See also
Commentary
The term is crucial in regulatory law, especially in FDA regulations; it designates drugs in the pipeline pending approval, distinguishing them from approved drugs.
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.