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VOICE ARCHIVE

Dr. Martin Makary

@drmakaryfda
3 posts
2025-06-03
Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30. Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.
2025-06-03 View on X
Axios

The US FDA debuts an agencywide generative AI tool to help scientific reviewers and others streamline work and, soon, to find high-priority inspection targets

from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people...

2025-05-10
We at the FDA now have to ask big questions that we've never asked before. Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We've just completed our first AI-assisted scientific review for a product and that's
2025-05-10 View on X
Fierce Biotech

The US FDA plans to deploy AI tools to all centers by June 30, 2025 to speed up scientific reviews, after completing a pilot and naming its first AI chief

FDA Artificial Intelligence AI and Machine Learning Biotech  —  The FDA has appointed its first chief artificial intelligence officer …

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
2025-05-10 View on X
Fierce Biotech

The US FDA plans to deploy AI tools to all centers by June 30, 2025 to speed up scientific reviews, after completing a pilot and naming its first AI chief

FDA Artificial Intelligence AI and Machine Learning Biotech  —  The FDA has appointed its first chief artificial intelligence officer …