> [FDA] will encourage researchers to use computer modeling and artificial intelligence to predict how a drug will perform, as well as organs-on-a-chip, which are miniaturized devices that mimic organs and tissues. And to determine effectiveness, the FDA will begin using existing, real-world safety data from other countries where a drug has already been studied in humans.
> FDA published a draft guidance in 2025 titled, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products.”
> [FDA] will encourage researchers to use computer modeling and artificial intelligence to predict how a drug will perform, as well as organs-on-a-chip, which are miniaturized devices that mimic organs and tissues. And to determine effectiveness, the FDA will begin using existing, real-world safety data from other countries where a drug has already been studied in humans.
Also from 2025: "FDA to Use A.I. In Drug Approvals to 'Radically Increase Efficiency'" https://news.ycombinator.com/item?id=44252183
(Edit)
From FDA > "Artificial Intelligence for Drug Development" https://www.fda.gov/about-fda/center-drug-evaluation-and-res... :
> FDA published a draft guidance in 2025 titled, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products.”