Lexology October 3, 2023
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence,” which expands upon how sponsors of drugs and biologics can rely on a single adequate and well-controlled clinical investigation and confirmatory evidence to support a finding of “substantial evidence” of effectiveness. The new draft guidance builds on prior guidance from 1998 and 2019 on single study applications, with the focus of the new guidance on the quantity and type of confirmatory evidence that FDA is likely to find persuasive.
FDA is seeking comments on the draft guidance through December 18.
Background
A drug’s effectiveness must be established by “substantial evidence,” which is defined...
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