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Regulatory Focus™ > News Articles > 2019 > 9 > Sentinel: FDA Expands Initiative With Two New Centers

Sentinel: FDA Expands Initiative With Two New Centers

Posted 30 September 2019 | By Michael Mezher 

Sentinel: FDA Expands Initiative With Two New Centers

The US Food and Drug Administration (FDA) on Friday said it has awarded a contract to Harvard Pilgrim Health Care and Deloitte Consulting to run two new coordinating centers for the agency's Sentinel Initiative.
First launched as a pilot in 2008, the Sentinel Initiative encompasses FDA's effort to meet obligations set by Congress in the 2007 Food and Drug Administration Amendments Act to develop a system for active postmarket risk identification and analysis for medical products.
Since then, FDA has agreed to further expand Sentinel's capabilities as part of its Prescription Drug User Fee Amendments (PDUFA VI) commitments.
The two new centers are the Sentinel Innovation Center and the Community Building and Outreach Center, which Gerald Dal Pan, director of the Office of Surveillance and Epidemiology, says, "will work with the Sentinel Operations Center to develop new technologies and enable stakeholders to grow the Sentinel System into a vigorous scientific community."
Under the five-year contract, Harvard Pilgrim will lead the Sentinel Innovation Center as well as the existing Sentinel Operations Center, and Deloitte Consulting will run the Sentinel Community Building and Outreach Center.
According to FDA, the Innovation Center will work on new methodologies for extracting and using data within Sentinel, while the Community Building and Outreach Center will focus on increasing stakeholder involvement and utilization 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," FDA writes, noting that Sentinel is "the largest multisite distributed database in the world dedicated to medical product safety."


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