After nearly a decade of machine learning innovation in the drug industry, the Food and Drug Administration Monday published its first draft guidance on the use of artificial intelligence in the development of drugs and biological products.
The guidance comes as drug regulatory submissions citing AI have increased exponentially. In an interview with STAT in October, the FDA’s Tala Fakhouri, who co-leads the Center for Drug Evaluation and Research’s AI Council, said the agency has received over 500 drug submissions with AI components since 2016, with a large number in the areas of oncology, neurology, and gastroenterology.
Industry members have described a shift in the last 18 months in regulatory bodies’ interest in how AI is used in drug development. The FDA’s new draft guidance comes on the heels of a reflection paper from the European Medicines Agency on the use of AI in the drug product lifecycle, finalized in September 2024. “Regulatory clarity is one of the top three barriers of adopting AI in this space,” said Xiaoyan Wang, senior vice president of life sciences solutions at clinical data company IMO Health.
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