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. – FDA Commissioner Dr. Martin Makary
In a significant strategic development, the FDA has successfully completed its initial AI-assisted scientific review pilot and is poised for agency-wide implementation by June 30, 2025.
Leading this transformative initiative is Jeremy Walsh, recently appointed as the FDA’s first Chief AI Officer. Walsh is charged with establishing a secure and internally integrated AI platform designed to maintain the integrity, accuracy, and confidentiality essential for regulatory oversight.
Under the leadership of Chief AI Officer Jeremy Walsh, the agency is exploring potential AI applications and has begun exploratory discussions with OpenAI.
Importantly, the FDA has initiated preliminary discussions with OpenAI regarding potential applications of AI in regulatory processes, including exploratory talks about an AI model referred to as "cderGPT," specifically targeted at enhancing processes within the Center for Drug Evaluation and Research. While these conversations reflect significant mutual interest, no formal collaboration or partnership has yet been finalized.
While this initiative promises increased efficiency and innovation, critical questions remain regarding transparency, accountability, and potential biases inherent in AI systems. Jim Czaban of Loeb & Loeb provides an insightful exploration of these open issues, emphasizing the importance of rigorous oversight as the FDA advances its ambitious AI agenda. Read more here.
Published May 26, 2025.
