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...

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Udgivet i:BMJ Open
Main Authors: Hatswell, Anthony J, Baio, Gianluca, Berlin, Jesse A, Irs, Alar, Freemantle, Nick
Format: Artigo
Sprog:Inglês
Udgivet: BMJ Publishing Group 2016
Fag:
Pharmacology and Therapeutics
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4932294/
https://ncbi.nlm.nih.gov/pubmed/27363818
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2016-011666
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