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.”
2020 Vision For FDA's Sentinel: 'Systemic' Integration Of Surveillance Looms
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 Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concerns
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Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
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England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
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Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.