Risks of FDA Draft Guidance on the Use of AI in Drug Development Centers

After nearly a decade of machine learning innovation in the pharmaceutical industry, the Food and Drug Administration on Monday released its first draft guidelines for the use of artificial intelligence in the development of drugs and biological products.

The guidance comes amid a sharp increase in drug regulatory submissions citing AI. FDA’s Tara Fakhouri, co-director of the Center for Drug Evaluation and Research’s AI Council, said in an October interview with STAT that the agency has received more than 500 drug applications with AI components since 2016. Most of them are in the following areas. Oncology, Neurology, Gastroenterology.

Industry players say regulators’ interest in how AI is used in drug development has shifted over the past 18 months. The FDA’s new draft guidance follows the European Medicines Agency’s reflection paper on the use of AI in the drug lifecycle, which was completed in September 2024. “Regulatory clarity is one of the top three barriers to implementing AI in this space,” said Xiaoyan Wang, senior vice president of life sciences solutions at clinical data company IMO Health.