FDA Bayesian Review Checklist

A structured checklist for navigating FDA's expectations on Bayesian adaptive designs, covering prior specification, borrowing mechanisms, operating characteristics, and sensitivity analyses.

What's Inside

• The prior robustness test FDA reviewers actually run
• Decision criteria and operating characteristics checklist
• Sensitivity analysis requirements
• 6 questions reviewers ask and how to answer them before they do
• Real-world examples from approved Bayesian submissions

How It Works

After purchase, you'll receive an email with a secure download link (valid for 7 days). If you need a new link, contact us at EvidenceintheWild.com.