The Role of Health-Related Quality of Life Data in the Drug Approval Processes in the US and Europe

  title={The Role of Health-Related Quality of Life Data in the Drug Approval Processes in the US and Europe},
  author={Patrick Marquis and M. Caron and M. P. Emery and Jane A. Scott and Benoit Arnould and Catherine Acquadro},
  journal={Pharmaceutical Medicine},
Objective: The objective of this research was to review the extent to which health-related quality of life (HR-QOL) and other patient-reported outcomes (PROs) have played a role in drug approval and labelling since 2006, when the US FDA issued its draft guidance on the use of PRO measures and the European Medicines Agency (EMA), its reflection paper on HR-QOL.Methods: This research was conducted through a systematic manual review of therapy area-specific regulatory guidelines (US and EU) and… 
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