Print Close

A regulatory review of case biologic products supported by a primary Bayesian analysis

Presented During: PS31: Case Studies of Statistical Borrowing in Clinical Trials: From Design to Regulatory Approval

Conference: ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2025

09/26/2025: 8:30 AM EDT - 9:45 AM EDT
Parallel

Description

In this presentation, I will discuss the regulatory perspectives on two recent approvals that were supported primarily by Bayesian analyses. Additionally, I will highlight some key points from the upcoming draft FDA guidance "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products."

Presenting Author

Lihan Yan, FDA