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In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry’s use of artificial intelligence (“AI”) to how the agency itself utilizes AI. This internal shift marks a departure from FDA’s development of AI guidance over the last few years.
2024 marked an active year for AI regulation by FDA, with establishment of the CDER AI Council as well as the development and release of various white papers and guidance documents. Even at the beginning of 2025, FDA…