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To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

Authors

  1. Correspondence to Professor Thomas Christian Kühler; thomas.kuhler{at}sanofi.com
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Citation

Kühler TC, Bujar M, McAuslane N, et al
To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

Publication history

  • Received December 21, 2018
  • Revised October 22, 2019
  • Accepted October 29, 2019
  • First published November 25, 2019.
Online issue publication 
November 25, 2019

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