FDA Sentinel Initiative

Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices.

Sentinel has developed the largest multisite distributed database in the world dedicated to medical product safety.

In September 2019, FDA announced Sentinel would expand to three distinct coordinating centers:

  • Sentinel Operations Center
  • Innovation Center
  • Community Building and Outreach Center

Operations Center

The Operations Center will continue to leverage organizational partnerships in the areas of

  • epidemiology
  • clinical medicine
  • pharmacy
  • statistics
  • health informatics
  • data science (specifically, artificial intelligence (natural language processing, machine learning)
  • network operations

to support postmarket safety analyses.

Innovation Center

The Innovation Center will develop innovative methods to further advance Sentinel, including exploring novel ways to extract and structure information from electronic health records in the future.

Community Building and Outreach Center

 The Community Building and Outreach Center’s will focus on communication and collaboration as well as deepening stakeholder involvement and broadening awareness, access, and use of Sentinel tools and data infrastructure.

This new design will enhance participation in a wider array of scientific expertise:

  • translate new technologies from emerging fields such as data science and big data
  • create laboratories to develop new approaches to using electronic health records
  • cultivate a robust scientific community to uncover novel ways to leverage the system’s core capabilities beyond drug safety


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