The US Food and Drug Administration (FDA) issued a draft guidance on Friday to assist sponsors in using Bayesian methods to support the safety and effectiveness of new drugs in clinical trials. These ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...

The FDA’s new draft guidance on Bayesian methods in clinical trials has been hailed by some as a breakthrough that could speed drug development. But statisticians and researchers are divided on ...

Bayesian methods offer a coherent framework for evaluating diagnostic tests by combining prior knowledge with observed data to yield posterior estimates of test accuracy and disease prevalence. At the ...

Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study We divided the borrowing ...

Bayesian methods offer a coherent framework for quantifying and propagating uncertainty by combining prior knowledge with experimental data. Unlike classical ...

Consistent with the Food and Drug Administration’s (FDA) commitment to streamlining the prescription drug and biologics approval processes by adopting innovative approaches to clinical trial design, ...

This course offers a rigorous yet practical exploration of Bayesian reasoning for data-driven inference and decision-making. Students will gain a deep understanding of probabilistic modeling, and ...

Approaches for statistical inference -- The Bayes approach -- Bayesian computation -- Model criticism and selection -- The empirical Bayes approach -- Bayesian design -- Special methods and models -- ...

Marty Makary was appointed commissioner of the Food and Drug Administration (FDA) in 2025. The prominent surgeon, medical researcher, bestselling author, and critic of the medical ...