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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.”

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