FDA emphasizes totality-of-the-evidence approach in revised “substantial evidence” draft guidance for drugs, biologics – FDA leadership provides additional context regarding “one pivotal trial” approach

July 23, 2026

In January 2026, (now former) U.S. Food and Drug Administration (FDA) leaders described a “single trial default” approach in a New England Journal of Medicine (NEJM) article, and in the months since, stakeholders have speculated about the meaning of a new policy announced outside of FDA’s guidance process….
By: Hogan Lovells Cadwalader

FDA emphasizes totality-of-the-evidence approach in revised “substantial evidence” draft guidance for drugs, biologics – FDA leadership provides additional context regarding “one pivotal trial” approach

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