On Jan. 14, 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly released the “Guiding Principles of Good AI Practice in Drug Development,” a set of 10 high-level principles intended to steer the safe and responsible use of AI across the product lifecycle. While not formal industry guidance, the document provides important insights into FDA and EMA thinking on the deployment of AI during drug and biologic product development and signals future regulatory guidance from both regulators. Read on for further details and takeaways for regulated industry.
