SentinelFDA 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


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