Recent United States Food and Drug Administration (FDA) announcements continue to highlight the agency’s increasing development and use of artificial intelligence. Earlier this month, FDA announced the launch of the latest version of Elsa – the internal AI solution it first announced last June. That same day, speaking at the Food and Drug Law Institute (FDLI) annual conference, the FDA Commissioner at the time, Dr. Martin Makary, announced a new pilot program for “one-day inspections” driven by AI-backed risk analysis for low-risk facilities. Taken together, and against the backdrop of Elsa’s launch less than a year ago, these developments show a continued push from FDA to leverage AI to expedite its operations, including in the enforcement space – a push that could have direct consequences for regulated entities across FDA product categories.
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