Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations - 10/14/2026

FDA's CDER SBIA announced an October 14, 2026 event on its draft guidance for Bayesian methods in drug and biological product trials. FDA says the event is for clinical trial, regulatory science and regulatory affairs professionals and includes a required recorded overview before a live panel discussion.

Why it matters: FDA lists prior distributions, missing data, software and analysis reporting among the topics relevant to designing trials with Bayesian methods.