A Potential Shift In FDA's Approach To Drug Trial Design

By Jessica Ritsick, Yifan Wang and Barbara Jones-Binns · February 19, 2026, 5:54 PM EST

On Jan. 9, the U.S. Food and Drug Administration issued a draft guidance document, "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products," which clarifies how Bayesian approaches may be...

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