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The FDA Sentinel Initiative — An Evolving National Resource

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    Description

    Authored by Sentinel and FDA investigators, this Perspective reviews Sentinel's evolution into a flexible and robust program that provides evidence on the effects of medical products while protecting patient privacy.  It also notes Sentinel's role in supporting FDA's plans to use Real World Evidence, and describes the program's progress in becoming a cornerstone of a learning health care system. 

    Author(s)

    Richard Platt, Jeffrey S. Brown, Melissa Robb, Mark McClellan, Robert Ball, Michael D. Nguyen, Rachel E. Sherman