FDA Endorses Bayesian Approach for Drug Approvals | PhaseV posted on the topic | LinkedIn
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FDA Endorses Bayesian Approach for Drug Approvals | PhaseV posted on the topic | LinkedIn
As FDA Commissioner Marty Makary M.D., M.P.H. says, the agency's new Bayesian guidance document is a potential game-changer in accelerating US drug approvals. Here are a few points that stood out for us at PhaseV: - FDA is formally endorsing the Bayesian statistical approach for general use (not just for complex innovative designs - CIDs), and ...
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