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Pharmaceuticals / Regulatory Affairs

FDA Releases Five-Year Plan for Sentinel System

Jan. 17, 2019

The FDA unveiled a five-year strategy for its Sentinel post-market safety surveillance system, detailing major goals through the year 2023.

The agency wants to create a more robust system that can make better use of the data Sentinel gathered over the past decade. It also plans to invest more heavily in machine learning and natural language processing.

“Sentinel is an integral part of FDA’s safety monitoring efforts. It’s a critical engine for methodological innovation, and a platform to advance the science of real world evidence,” FDA Commissioner Scott Gottlieb said.

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