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# Webinar on FDA’s Bayesian Draft Guidance
- URL: https://www.fdaweb.com/webinar-on-fdas-bayesian-draft-guidance/
- Published: 2026-08-25T12:00:00.000Z
- Updated: 2026-09-14T12:05:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161676

FDA is announcing a 10/14 Webinar on its recent draft guidance on *Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.* The document details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to support approvals. FDA says Bayesian methods can play a role across drug development, including adaptive interim analyses, dose selection, and the design of follow-on studies. The primary focus of the guidance, however, is on the use of Bayesian methods to support primary inference — the main efficacy and safety conclusions relied upon in regulatory decision-making.

According to an [FDA notice](https://www.fda.gov/drugs/news-events-human-drugs/navigating-fda-bayesian-draft-guidance-design-analysis-and-review-considerations-10142026?ref=fdaweb.com) (includes a link to the guidance), topics covered include:

- Success criteria and operating characteristics in Bayesian trials
- Considerations for prior distributions
- Additional topics including missing data and estimands, software usage, documenting and reporting expectations for Bayesian analyses
- Descriptions of specific settings where Bayesian methods have been previously used.