FDA to Host Webinar on Bayesian Draft Guidance for Clinical Trials
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FDA's CDER Small Business and Industry Assistance unit will hold a free virtual webinar on October 14, 2026, from 12:00 to 1:00 p.m. ET, on the agency's January 2026 draft guidance "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products." The guidance fulfills a PDUFA VII commitment. Speakers include John Scott of CBER and CDER statisticians James Travis and Van Tran, who will cover success criteria, operating characteristics, prior distributions, estimands, missing data, and software and reporting expectations. The session is aimed at trial, regulatory science and regulatory affairs professionals; Bayesian methods are most relevant to pediatric and rare disease trials. Registration is free and the event is virtual.
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- fda.govPickNavigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations - 10/14/2026
FDA's CDER Small Business and Industry Assistance unit will host a free virtual webinar on October 14, 2026, 12:00-1:00 p.m. ET, on the January 2026 draft guidance "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products," which addresses a PDUFA VII commitment. Speakers include John Scott of CBER and CDER statisticians James Travis and Van Tran, covering success criteria, operating characteristics, prior distributions, estimands, missing data, software and reporting expectations. The guidance is aimed at trial, regulatory science and regulatory affairs professionals, with Bayesian methods most relevant to pediatric and rare disease trials.
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