Federal News Update: FDA Releases Guidance on Modernizing Statistical Methods in Clinical Trials
Emma Davidson
By Patrick Cooney, for AMRC
FEDERAL AGENCY NEWS
FDA Releases Guidance on Modernizing Statistical Methods in Clinical Trials
On January 12, 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics; Draft Guidance for Industry, marking a significant step toward modernizing statistical approaches in clinical research. This guidance is now open for public comment as part of the agency’s commitment under...