FDA's Sentinel Initiative
Transforming how we monitor the safety
of FDA-regulated products
Sentinel Initiative
Monitoring the safety of its regulated products is a major part of the FDA’s mission to protect public health. 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. In response to the FDA Amendments Act (FDAAA) of 2007, in May 2008 the FDA launched the Sentinel Initiative.
The first phase of this initiative was the Mini-Sentinel Pilot to inform the development of the Sentinel System. In September 2014, the FDA began transitioning from the Mini-Sentinel phase to the full Sentinel System, which officially launched in February 2016. Over time, Sentinel has developed the largest multisite distributed database in the world dedicated to medical product safety. It is constantly growing and improving to meet FDA’s needs.
In September 2019, FDA announced Sentinel would expand to three distinct coordinating centers: Sentinel Operations Center, Innovation Center, and Community Building and Outreach 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)), and network operations to support postmarket safety analyses. 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. 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 to 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, and cultivate a robust scientific community to uncover novel ways to leverage the system’s core capabilities beyond drug safety.
The Sentinel Collaborators
| Center | Collaborator |
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Sentinel Operations Center |
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Sentinel Innovation Center |
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Sentinel Community Building and Outreach Center |
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