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2020 Vision For FDA's Sentinel: 'Systemic' Integration Of Surveillance Looms

 
• By Michael McCaughan

PDUFA reauthorization agreement sets up fiscal 2020 as milestone for weaving active surveillance into drug review – and for keeping sponsors informed of activities that affect their products.

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The PDUFA VI user fee agreement negotiated by FDA and industry envisions the year 2020 as a critical milestone for FDA’s Sentinel active surveillance system: that is when the agency is committing to integrate Sentinel “into the human drug review program in a systematic, efficient and consistent way.”

The deadline is articulated via three specific deadlines outlined in Section I.K.1 of the "commitment letter" released by FDA for public comment on July 15. By the end...

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