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# New 5-Year Sentinel Strategy
- URL: https://www.fdaweb.com/new-5-year-sentinel-strategy/
- Published: 2019-01-09T12:00:00.000Z
- Updated: 2026-09-15T00:53:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143116

FDA commissioner **Scott Gottlieb** says the agency is launching a new five-year strategy that envisions a more robust Sentinel System that operates as a transformative national resource. Sentinel is a national electronic system for monitoring the safety of FDA-approved drugs and other medical products.

Writing with CDER Office of Surveillance and Epidemiology director **Gerald Dal Pan** in an *FDA Voices* online [post](https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm629326.htm?ref=fdaweb.com), Gottlieb says the “data and scientific resources will function as a multi-purpose center for evidence generation with the potential to be used by more stakeholders and inform all aspects of healthcare decision-making.”

The [strategy](https://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM629243.pdf?ref=fdaweb.com) lists five strategic goals to be reached by 2023: 

- enhance and expand the Sentinel System’s foundation, including data, infrastructure, operations, and technology;
- augment Sentinel’s safety analysis capabilities using advances in data science and signal detection;
- use the Sentinel System to accelerate access to and broaden use of real-world data for real-world evidence;
- broaden the Sentinel System’s ecosystem of stakeholders to pursue the vision of a national resource; and
- disseminate knowledge and advance regulatory science to encourage innovation and meet the agency’s scientific needs.

The agency is planning a 4/3-4/5 [workshop](https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm149341.htm?ref=fdaweb.com) at which stakeholders can discuss the vision of the plan with FDA staff. “The cumulative impact of all five aims of this new plan will be substantial,” Gottlieb and Dal Pan conclude. “It will allow stakeholders to continually discover new approaches to growing the Sentinel System’s capabilities for the next five years and beyond.”