FDA Issues Sentinel Five-Year Strategic Plan

January 11, 2019

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

On Jan. 9, 2019, FDA issued the Sentinel 5-Year Strategic Plan: 2019-2023, a plan that lays out major goals for the future of the Sentinel System, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, and FDA Catalyst, which leverages the Sentinel infrastructure and other capabilities of the system to answer a wider range of questions than can be addressed by the system data alone.

The agency states that the plan is intended to serve as a roadmap to guide the development of Sentinel over the next five years. Specifically, the plan discusses five strategic aims:

  • enhance and expand the system’s foundation (i.e., data, infrastructure, operations, technology)

  • augment the system’s safety analysis capabilities by leveraging advances in data sciences and signal detection

  • leverage the system to accelerate access to and broader use of real-world data for real-world evidence generation. 

  • increase the system’s stakeholders for nationwide influence. 

  • disseminate knowledge and advance regulatory science to encourage innovation and meet agency scientific needs. 

The plan will be discussed at the next Annual Sentinel Public Workshop on April 3–5, 2019 in Bethesda and Silver Spring, MD, in which FDA will share recent developments within the Sentinel Initiative, provide training on system’s tools and data infrastructure, and promote engagement and collaboration with patients, industry, and consumers. 

Source: FDA