Phase IV Clinical Trial
Post-marketing surveillance studies conducted after drug approval. Detect rare adverse events, evaluate long-term safety, explore new indications, and study drug use in special populations.
Examples
- REMS requirements
- Observational studies
- Registry-based studies
Did You Know?
Post-marketing surveillance studies conducted after drug approval. Detect rare adverse events, evaluate long-term safety, explore new indications, and study drug use in special populations.