On January 6, the U.S. Food and Drug Administration (FDA) issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality. A press release announcing the guidance is available at https://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissions.

This is the first guidance the agency has issued on the use of AI for the development of drug and biological products. The FDA’s human and animal medical product centers, along with the agency’s Office of Inspections and Investigations, Oncology Center of Excellence, and Office of Combination Products worked collaboratively on this draft guidance to ensure consistency across the agency. In developing these recommendations, the FDA incorporated feedback from interested parties including sponsors, manufacturers, technology developers and suppliers, and academics.

FDA is accepting comment on the draft guidance through April 7. A Federal Register notice providing instructions on how to submit comments is available at https://www.federalregister.gov/d/2024-31542. Links to the draft guidance document and the Federal Register notice are available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological.