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Sentinel Safety Surveillance Not Ideal For Every Product, Reports Find

This article was originally published in The Gray Sheet

Executive Summary

Before considering whether to use its nascent Sentinel safety surveillance system, FDA should see whether traditional methods might work just as well, according to two reports commissioned by the agency

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NEJM Editorialists: Sentinel System Feasible, But Presents Challenges

FDA's post-market surveillance Sentinel Initiative comes with some steep challenges, several health policy experts write in the New England Journal of Medicine July 27

NEJM Editorialists: Sentinel System Feasible, But Presents Challenges

FDA's post-market surveillance Sentinel Initiative comes with some steep challenges, several health policy experts write in the New England Journal of Medicine July 27

Chart: Sentinel Initiative Starts Life With Eight Evaluation Contracts

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