Jessica Ritsick, Yifan Wang, Ph.D. Our FDA: Drug & Device Team analyzes the Food and Drug Administration’s new guidance on Bayesian approaches to innovative drug trials, providing greater clarity on ...
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 ...
In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is ...
As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...
The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.