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Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999โ2014
The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence.To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).Drug approval โฆ