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FDA’s Sentinel Strategy: Starting Slow Move Toward “Active” Surveillance

 
• By Cole Werble

US FDA’s strategic plan for Sentinel includes pilot projects to move towards the vision of active surveillance. However, FDA is also making clear that it won’t be a quick or easy transformation. 

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The US FDA is outlining plans to expand its Sentinel drug safety system into active surveillance/signal identification – but is emphasizing that it will be a long trek, even with more than 10 years of experience using the system to investigate specific safety questions.

The effort is one component of FDA’s just-released five-year 2019-2023 strategic plan for all Sentinel activities, and the agency previewed its plan to start the undertaking on a pilot...

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