Insight

May 9, 2025, 13:55

FDA Announces Aggressive Timeline to Scale 1st AI-Assisted Scientific Review Pilot

Martin Makary, 27th Commissioner of the U.S. FDA, shared a post by U.S. FDA on X, adding:

“I was blown away by the success of our first AI-assisted scientific review pilot. We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

Quoting U.S. FDA‘s post:

“In a historic first for the agency, Martin Makary today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.

To reflect the urgency of this effort, Dr. Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality and adapt to the evolving needs of each center after June 30.

By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.”

FDA

This announcement comes as the FDA revealed the completion of its first generative AI pilot to support scientific reviewers, marking a historic milestone for the agency. The pilot demonstrated significant efficiency gains and has triggered an agency-wide mandate for full-scale AI integration across all FDA centers by June 30, 2025.

Dr. Makary has directed all centers to begin immediate deployment, with the goal of a unified, secure AI system fully operational within the next year. The initiative aims to reduce administrative burden, streamline internal workflows, and expedite the evaluation of new therapies.

More posts featuring Martin Makary and FDA on OncoDaily.