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FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

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European Commission specifies post-authorization efficacy study guidelines

European Commission specifies post-authorization efficacy study guidelines

11-04-2014

The European Commission has adopted a delegated act specifying the situations where a post-authorization…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalPharmaceutical industryPharmaceutical sciencesPharmacologyRegulationResearch

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