Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations October 14, 2026

https://www.fda.gov/drugs/news-events-human-drugs/navigating-fda-bayesian-draft-guidance-design-analysis-and-review-considerations-10142026?utm_medium=email&utm_source=govdelivery Join SBIA for its Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations! This webinar will provide an in-depth overview of FDA's January 2026 draft guidance on the use of Bayesian methodology in clinical trials of drug and biological products, a PDUFA VII commitment, and its implications for trial design and analysis. You should attend if you’re a clinical trial, regulatory science and regulatory affairs professional working on clinical trials and studies where Bayesian methods can potentially be used as an alternative statistical approach. Such uses are most beneficial in settings where it is appropriate to leverage information from previous studies or use adaptive designs. The most common settings include pediatric and rare disease trials. FDA experts will walk through guidance topics including success criteria and operating characteristics in Bayesian trials, considerations for prior distributions, missing data and estimands in a Bayesian framework, documentation and reporting expectations, and more. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.