December 2018 – Drug and Device Digest

Patients Matter and Patient Engagement

Patient Engagement

Individual patient

  • experience diseases and therapies differently
  • has unique perspective about treatments or diagnostic procedures

Opportunities for patients and caregivers to get involved with FDA

  • Evolution of Patient Engagement at FDA
  • Patient Engagement Collaborative
  • FDA and European Medicines Agency Patient Engagement Cluster
  • FDA Patient Council
  • MOU with the National Organization of Rare Disorders
  • FDA Patient Representative Program
  • Food and Drug Administration Safety and Innovation Act (FDASIA) Section 1137
  • Patient Reported Outcomes
  • Patient Focused Drug Development Initiative
  • Device Patient Preference Initiative
  • Devices Patient Engagement Advisory Committee
  • Additional Patient Resources


Video credit: FDA

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