FDA framework to advance AI models used for drug and biological filings

The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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.

The agency noted that this is the first guidance the FDA has issued on the use of AI for the development of drug and biological products.

In developing these recommendations, the FDA says it incorporated feedback from a number of interested parties including sponsors, manufacturers, technology developers and suppliers, and academics. Specifically, this draft guidance was informed by feedback from an FDA-sponsored expert workshop convened by the Duke Margolis Institute for Health Policy in Dec. 2022, more than 800 comments received from external parties on two discussion papers published in May 2023 on AI use in drug development and in manufacturing, and the FDA’s experience with more than 500 drug and biological product submissions with AI components since 2016