FDA Sentinel System
FDA Sentinel System
Sentinel is used by the FDA-CDER to assess the safety of prescription drugs, including biological therapeutics and generic drugs
- Managed in CDER’s Office of Surveillance and Epidemiology
- Important component of CDER’s postmarketing safety system
- Used to proactively assess drug safety, under real-world conditions, that more closely reflect patient care
- Sentinel assessments make use of the automated surveillance tools
Image credit: Sentinel/FDA