CDER is committed to ensuring that drugs are safe and effective while facilitating innovations in their development. FDA published a draft guidance in 2025 titled, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products.”
This guidance provides recommendations to industry on the use of AI to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. The content of this draft guidance was informed by (1) feedback received in December 2022 as part of an expert workshop convened by the Duke Margolis Institute for Health Policy on behalf of CDER/FDA; (2) over 800 comments received from external parties on the discussion paper published in May 2023 on AI use in drug development; (3) CDER’s experience with over 500 submissions with AI components from 2016 to 2023; and (4) a hybrid public workshopExternal Link Disclaimer for interested parties held on August 6, 2024 to discuss the guiding principles for the responsible use of AI in the development of safe and effective drug and biological products.