FDA Urged To Weigh Patient Perspective, Real-World Data In PDUFA Talks

Drug industry, patient and consumer urged FDA to home in on some key issues as it begins talks on the next Prescription Drug User Fee Act (PDUFA): chiefly, how to better integrate the patient perspective into drug development and regulatory decision-making, and a need to develop and validate methodologies to use real-world data. A key pharmaceutical stakeholder group added that clarity is needed on how to translate patient preference information into tangible outcomes. FDA kicked off the PDUFA VI processes...