The FDA’s Shift to One Pivotal Trial: What It Means for Modern Development Programs
Seth DePuy
In February 2026, the Food and Drug Administration (FDA) outlined a meaningful evolution in the Agency’s evidentiary approach to drug approval: establishing one adequate and well-controlled trial, supported by confirmatory evidence, as the default basis for marketing authorization. This position was articulated in The New England Journal of Medicine in “One Pivotal Trial, the New... The post The FDA’s Shift to One Pivotal Trial: What It Means for Modern Development Programs appeared first on Pre