ACDM News Item

Recent update from the regulatory landscape in clinical data management

Date: August 3, 2026

Thank you to the Regulatory Considerations DMEG for sharing this update.

On July 15 the FDA’s CDER posted their 2026 guidance agenda. The FDA uses this agenda to tell industry what guidance they plan to publish in 2026.

One of these new guidance documents is: Computer Software Assurance for AI-Based Systems in Drug Manufacturing and Clinical Investigations; Supplemental Guidance.

This document appears to be a separate document from the current draft guidance titled: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.

Some other planned guidance of interest to data managers include:

Engaging with FDA to Discuss the Use of Digital Health Technologies in Clinical Investigations of Drug and Biological Products

Master Protocols for Drug and Biological Product Development; Revised Draft4

Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA Regulated Medical Products; Revised Draft

The ACDM DMEG for Regulatory Considerations plans to review these guidance as they are posted to evaluate the impact on data management.

Please find a copy of the agenda here: https://acdmglobal.org/wp-content/uploads/2026/08/CDER-2026-Guidance-Agenda_07.2026.pdf

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