Calibrated Bayes: The Framework You’re Already Using
If you’ve ever justified a Bayesian design to a regulator, you’ve already been practicing calibrated Bayes, even if you never called it that.
Regulatory Science
Inside the First FDA-Approved Bayesian Analysis
What REBYOTA teaches us about dynamic borrowing
The FDA's Bayesian Guidance: Learning in Theory, Pre-Specification in Practice
The FDA just gave us 25 pages on Bayesian inference in pivotal trials. The philosophical message is clear: Bayesian methods are welcome. Informative priors, borrowing from external data, direct interpretation of posterior probabilities were all explicitly endorsed. The operational message is different: pre-specify everything. Bayesian methods promise learning. Regulators demand