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  1. 781

    TRUMP ve AVRUPA TRANSATLANTİK DÜZENDE KIRILMA by Çağatay Özdemir

    Published 2019-08-01
    Subjects: “…us…”
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    Foundation Networks and American Hegemony by Inderjeet Parmar

    Published 2012-02-01
    Subjects: “…Philanthropic foundations; US hegemony; elite knowledge networks; Rockefeller; Ford; Carnegie…”
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    Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017 by Bao Liu, Xingyue Zhu

    Published 2022-07-01
    “…Objective To explore the associations between the risks of postmarketing safety events of new drugs and the four expedited programmes of priority review, accelerated approval, fast track and breakthrough therapy established by the US Food and Drug Administration (FDA); and to investigate whether multiple uses of expedited programmes, and the combinations of expedited programmes with orphan designation, were relevant to different safety profiles.Design Cohort study.Setting USA.Participants All new drugs approved by the FDA between 1 January 2007 and 31 December 2017, followed up until 10 April 2021.Outcome measures Safety events included safety-related withdrawal, new boxed warning, drug safety communication, postapproval risk evaluation mitigation strategy and safety-related labelling changes. …”
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