FDA shifts to single-trial standard as broader reforms roil vaccine oversight

The US regulator reportedly will move to a single-trial default for most drug and biologic approvals, marking the agency’s most significant procedural reset in decades.

Commissioner Marty Makary told reporters that the Food and Drug Administration will generally require one well-designed pivotal study rather than the long-standing expectation of two, though complex programs may still need additional evidence.

Dr Makary said a single, tightly controlled trial can deliver equivalent statistical power, reflecting a trend already seen across many submissions. The change is expected to accelerate timelines for developers while raising questions about how the agency will balance speed with robustness during a period of political flux.