This report describes stakeholder engagement achieved in FY 2013, and fulfills FDA’s PDUFA commitment to issue a report of its findings regarding REMS standardization. It includes suggestions and recommendations received from stakeholders through a variety of methods (public meetings, Advisory Committee meetings, an expert panel workshop, and comments received electronically as well as through teleconferences). Stakeholder feedback guided the Agency in selecting four priority projects within the areas specified by PDUFA V.