The U.S. Food and Drug Administration (FDA) is introducing a voluntary agentic AI tool for employees to enhance complex AI-driven workflows. This initiative aims to streamline multi-step tasks across various areas, including meeting management, pre-market reviews, post-market surveillance, and compliance inspections. “We are expanding our use of AI to equip our reviewers and scientists with modern tools to accelerate cures and treatments,” stated FDA Commissioner Marty Makary, M.D., M.P.H. The FDA also announced a two-month Agentic AI Challenge for staff to develop innovative AI solutions, culminating in presentations at the FDA’s Scientific Computing Day in January 2026. Chief AI Officer Jeremy Walsh emphasized that this powerful tool will assist reviewers in improving the safety and efficacy of regulated products. By adopting this cutting-edge technology, the FDA aims to modernize operations and enhance its mission to protect public health.
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