The US Food and Drug Administration (FDA) has issued its first draft guidance on the use of artificial intelligence (AI) in drug development. This move comes as submissions citing AI in drug regulatory filings have increased significantly.
Since 2016, over 500 drugs with AI components have been submitted to the FDA, with a focus on oncology, neurology, and gastroenterology treatments. Industry experts say that there has been a notable shift in regulatory bodies’ interest in how AI is used in drug development over the past year.
The new guidance aims to provide clarity for industry members looking to adopt AI in this field. In related news, the European Medicines Agency (EMA) released a reflection paper on using AI in the entire lifecycle of drugs last September. According to Xiaoyan Wang, senior vice president at clinical data company IMO Health, “regulatory clarity is one of the top barriers to adopting AI in this space.”
Source: https://www.statnews.com/2025/01/06/artificial-intelligence-use-drug-development-fda-draft-guidance