Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017

Objectives To assess the use, and evaluate the usefulness, of non-interventional studies and routinely collected healthcare data in postmarketing assessments conducted by the European Medicines Agency (EMA).Design We reviewed and systematically assessed all referrals to the EMA made due to safety or...

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Bibliographic Details
Main Authors: Kevin Wing, Krishnan Bhaskaran, Jeremy Philip Brown, Stephen J Evans, Ian J Douglas
Format: Article
Language:English
Published: BMJ Publishing Group 2019-10-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/10/e028133.full
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