Post-Marketing Surveillance
/ˈpoʊstˌmɑrkɪtɪŋ ˌsɜrvəˈleɪəns/
Definitions
- (n.) Ongoing monitoring of a pharmaceutical drug or medical device after it has been released on the market, aimed at detecting adverse effects and ensuring continued safety and efficacy.
Regulators require post-marketing surveillance to identify long-term side effects not observed in clinical trials.
Forms
- post-marketing surveillance
Related terms
See also
Commentary
Post-marketing surveillance is critical in regulatory law for risk management and informs possible restrictions or recalls after product approval.
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.