Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products Draft Guidance for Industry January 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-bayesian-methodology-clinical-trials-drug-and-biological-products?utm_medium=email&utm_source=govdelivery FDA recently published the guidance snapshot and podcast for the draft guidance Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics. FDA’s Guidance Snapshot Pilot Program aims to increase the general public’s awareness of and engagement with FDA guidance documents—and support the efficient application of recommendations. The snapshot highlights key points in the guidance document and is not a substitute for the guidance document. The podcast provides highlights and background about the guidance through a conversation with FDA staff. https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot?utm_medium=email&utm_source=govdelivery The Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics draft guidance provides recommendations on the appropriate use of Bayesian methods, with an emphasis on the use of these methods to support primary inference. Bayesian methods may be especially valuable for sponsors targeting rare or pediatric indications, where patient populations are smaller. https://www.fda.gov/media/191685/download?attachment=&utm_medium=email&utm_source=govdelivery