The FDA’s new draft guidance on Bayesian methods in clinical trials has been hailed by some as a breakthrough that could speed drug development.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 ...
The FDA's move to incorporate Bayesian statistical methods into clinical trials of drugs and biologics garnered special treatment in JAMA this week. JAMA published three perspectives -- two welcoming ...
Industry groups and drugmakers want the US Food and Drug Administration (FDA) to explicitly clarify that Bayesian statistical methods can be used for products beyond those intended for children and ...
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 ...
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 ...