Phase Iv Trial
/ˈfeɪz ˈaɪ vi ˈtraɪəl/
Definitions
- (n.) A post-marketing clinical study conducted to gather additional information on a drug's risks, benefits, and optimal use after FDA approval.
The pharmaceutical company initiated a phase iv trial to monitor long-term side effects of the new medication.
Forms
- phase iv trial
- phase 4 trial
Related terms
See also
Commentary
Phase IV trials are legally significant because they may impact labeling requirements and post-market regulatory obligations under FDA law.
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.