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Business · 12/01/2026Updated: 10/16/2026 · 1 min read

FDA Announces Draft Guidance on Bayesian Methodology in Clinical Trials

Summary

The FDA has released a draft guidance for industry on the use of Bayesian methodology in clinical trials of drug and biological products, focusing on pivotal trials supporting effectiveness and safety.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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