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Califf Puts Weight Behind 'Sentinel' As Evidence-Generation System Of The Future

This article was originally published in The Gray Sheet

Executive Summary

Industry is increasingly supporting the "Sentinel" system for tracking postmarket product performance with claims and other real-world tools. But more companies need to be convinced of the value of the effort in advancing development of next-generation products, rather than simply a tool for safety surveillance, FDA Commissioner Robert Califf told members of the Alliance for a Stronger FDA.

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