The Prescription Drug User Fee Act (PDUFA) is set to be reauthorized by September 30, 2022, with new milestones and goals aimed to drive innovation, agility, and transparency. Along with the PDUFA VII commitment letter agreement, there is a potential for additional new policies to be implemented via legislation. Join us in a panel discussion describing the opportunities and considerations for development programs that needs to be taken into account as PDUFA VII and potential new policies are authorized so that new medicines can continue to be provided in an efficient manner to patients.