The FDA's sentinel initiative--A comprehensive approach to medical product surveillance

Clin Pharmacol Ther. 2016 Mar;99(3):265-8. doi: 10.1002/cpt.320. Epub 2016 Jan 12.


In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products.

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Equipment and Supplies / adverse effects
  • Equipment and Supplies / standards
  • Humans
  • Pharmacovigilance
  • Product Surveillance, Postmarketing*
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*