• RF QuarterlyFeature ArticlesFeature Articles

    FINALIST Patient-reported outcomes and patient preference information in regulatory decision making

    This article discusses the patient-focused trends in collecting patient experience data (PED), such as patient-reported outcomes (PROs) and patient preference information (PPI), for use in regulatory decision making and drug development. The authors cover current programs initiated by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and discuss how the agencies and sponsors can collaborate to elevate the role of PROs and PPI in informing regula...
  • RF QuarterlyFeature ArticlesFeature Articles

    ICH implementation: The transition from convergence to harmonization

    This article examines the transition from convergence to harmonization for global pharmaceutical regulatory requirements. It outlines the roles of International Council for Harmonisation (ICH) and World Health Organization (WHO) in the implementation of ICH guidances and provides definitions for convergence and harmonization to reflect their distinctive roles. The authors also address ongoing harmonization initiatives, the current degree to which implementation has or has ...