• RF Quarterly
    Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    Preparing for High-Stakes Regulatory Meetings in the US and Europe

    This article provides regulatory professionals with an understanding of the specifics of FDA Advisory Committee (ADCOM) and Committee for Medicinal Products for Human Use (CHMP) Oral Explanation (OE) meetings. The authors outline key guiding principles to help regulatory teams more effectively structure their preparation timelines, bring focus to their pre-meeting work and ensure they perform well on meeting day.   The article is based on a presentation by the authors ...