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Expert Analysis

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and Barbara Jones-Binns ( February 19, 2026, 5:54 PM EST) -- On Jan. 9, the U.S. Food and Drug Administration issued draft guidance clarifying how Bayesian approaches may be used in clinical trials to support regulatory decision-making. It reflects the agency's continued interest in innovative trial designs that may accelerate new drug approvals, especially for treatments addressing unmet medical needs. ...

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