FDA's Center for Drug Evaluation and Research walks sponsors through its Bayesian methodology draft guidance in a free online session — , noon–1 p.m. ET — pairing a required, self-paced pre-recorded module with a live panel discussion from the reviewers who wrote it.
Dates and format
- Date: 14 October 2026, 12:00–1:00 p.m. ET
- Format: online — a required pre-recorded video, watched at your own pace, followed by a live panel discussion
- Organizer: FDA Center for Drug Evaluation and Research (CDER)
- Panelists: James Travis, PhD; Van Tran, PhD; Mark Rothmann, PhD (Division Director)
What it covers
In January 2026, FDA issued draft guidance on the use of Bayesian methodology in clinical trials of drug and biological products, addressing a PDUFA VII commitment. The guidance covers success criteria and operating characteristics, how to incorporate external information into a prior distribution, estimands and missing data under a Bayesian design, software and computational considerations, and how sponsors should document and report Bayesian analyses. This session's pre-recorded module lays out those considerations, and the live panel — staffed by FDA's own biometrics reviewers — takes questions on how they apply to trial design in practice.
Who should attend
Biostatisticians, clinical trial designers, and regulatory affairs leads at sponsors considering or already running Bayesian-design trials for drugs or biologics. The session is free and requires only the pre-recorded module ahead of the live panel. FDA's Conversations on Cancer webcast covers a different OCE initiative the same season, RAPS's Biologics CMC workshop takes up a related development-stage topic, and the full events directory lists everything we have verified.
Frequently asked questions
When is FDA's Bayesian draft guidance webinar?
14 October 2026, noon to 1 p.m. Eastern Time, held online. It begins with a required pre-recorded video you can watch at your own pace before the live panel discussion.
What guidance does it cover?
FDA's January 2026 draft guidance, "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products," issued to address a PDUFA VII commitment — covering success criteria, use of external information in a prior distribution, estimands and missing data, software and computation, and documentation.
Who is on the panel?
James Travis, PhD (Master Mathematical Statistician, Division of Biometrics II); Van Tran, PhD (Senior Mathematical Statistician, Division of Biometrics VII); and Mark Rothmann, PhD (Division Director), all from FDA's Center for Drug Evaluation and Research.
Is there a fee?
No. FDA's event page lists it as free to attend.
Sources & further reading
- FDA. Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations, 10/14/2026. fda.gov
- Federal Register / FDA. Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability, 01/12/2026. federalregister.gov
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of FDA's own event page rather than a direct fetch, because this session's network egress could not reach fda.gov directly — confirm dates and access with FDA before making plans. Last verified 28 September 2026.
