EMA And FDA Claim 'High Concordance' In Approval Decisions

 
• By Neena Brizmohun

Divergences between the EU and US agencies in marketing application approval decisions in 2014-2016 were primarily due to differences in the regulators’ conclusions about efficacy based on review of the same data or to differing clinical data submitted to support the application, a study has revealed.

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The EMA and FDA say concordance in their approval decisions is high • Source: Shutterstock

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