| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 12 Jan 2026 | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products | Draft | This document provides guidance to sponsors and applicants submitting INDs, NDAs, BLAs, or supplemental applications on the appropriate use of Bayesian methods in clinical trials. Bayesian methods can be used in various ways in clinical trials. For example, Bayesian calculations can be used to govern the timing and adaptation rules for an interim analysis in an adaptive design, to inform design elements (e.g., dose selection) for subsequent clinical trials, or to support primary inference in a trial. The primary focus of this guidance is on the use of Bayesian methods to support primary inference in clinical trials intended to support the effectiveness and safety of drugs. |
| 6 Jan 2026 | Clinical Decision Support Software (Medical Devices) | Final | This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices. Not all clinical decision support software used in healthcare settings are devices and therefore subject to FDA oversight as a device. The purpose of this guidance is to describe FDA’s regulatory approach to CDS software functions. |
Pharmavibes
medicines-medical devices-regulatory affairs