Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input

RTI's Steve Cohen will be among the panelists during the U.S. Food and Drug Administration's public workshop “Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input.”

The workshop, being held December 18, 2017 in Silver Spring, MD, will discuss acceptable methodological approaches for collecting patient experience data for submission to FDA to inform regulatory decision-making, including approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. This workshop will be used to inform patient-focused drug development guidance as required by the 21st Century Cures Act and to meet a performance goal included in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI).