In February 2025, the FDA released an updated discussion paper to inform stakeholders about the evolving role of artificial intelligence in drug development.

This discussion paper aims to shed light on both current and potential future applications of AI within the pharmaceutical industry.

The document emphasizes AI's transformative impact across various stages of drug development, including target identification, pharmacokinetics and pharmacodynamics modeling, and clinical data analysis.

AI is now being integrated into nearly every aspect of the drug development process, marking a significant shift in how new medicines are researched and brought to market.