منابع مشابه
Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014
INTRODUCTION The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. OBJECTIVE 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). METHODS Drug approval data were downloade...
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ژورنال
عنوان ژورنال: Journal of General Internal Medicine
سال: 2019
ISSN: 0884-8734,1525-1497
DOI: 10.1007/s11606-019-05408-6