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

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.

FDA Commissioner Robert Califf senses growing support from industry for the "Sentinel" system for tracking postmarket product performance using insurance claims and other data that is currently applied to pharmaceuticals, and is now moving into the device arena.

"If you look at the department [user-fee] negotiations that are going on now, I'd say that something like Sentinel – which I think is incredibly creative – and that it's being supported by the industry … is a remarkable achievement," the

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