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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:
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.