Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016–2024

Real-world evidence studies are infrequently used to support the U.S. Food and Drug Administration's premarket determinations of effectiveness and/or safety but have been increasingly required or requested by the U.S. Food and Drug Administration to be conducted postmarket after approval; however delays in completing postmarket real-world evidence studies may limit their regulatory impact.