FDA outlines AI approach for drug development

FDA says AI is being used more widely across the drug product life cycle, including nonclinical, clinical, postmarketing, and manufacturing phases. CDER has seen a significant rise in submissions with AI components, with growing activity tied to Digital Health Technologies and Real-World Data analytics.

CDER’s approach centers on enabling innovation while ensuring drugs remain safe and effective. FDA published draft guidance in 2025 on the use of AI to support regulatory decision-making for drug and biological products, drawing on public feedback, workshops, and CDER’s experience with over 500 submissions with AI components from 2016 to 2023.

The CDER AI Council, established in 2024, is intended to coordinate AI policy, internal capabilities, communications, and regulatory consistency across the center. CDER and CBER also worked with the European Medicines Agency on 10 guiding principles for AI use in drug and biological product development.