During the last eight years, the US Food and Drug Administration (FDA) has been increasingly focused on realising a vision—to incorporate patient input in drug development and regulatory decision-making as standard practice. Deborah Komlos at Clarivate Analytics looks at how both the Patient-Focused Drug Development (PFDD) initiative and the reauthorisation of the Prescription Drug User Fee Act (PDUFA) are more adept at systematically obtaining the patient perspective on specific diseases and their currently available treatments.