Advancing AI model credibility: Proposed FDA framework
The U.S. Food and Drug Administration (FDA) has published the first drug guidance regarding “the use of artificial intelligence (AI) for the development of drug and biological products,” according to an announcement.
The draft guidance will “provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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.”
Additionally, “this guidance provides a risk-based framework for sponsors to assess and establish the credibility of an AI model for a particular context of use and determine the credibility activities needed to demonstrate that an AI model’s output is credible. This approach is consistent with how FDA staff have been reviewing applications for drug and biological products with AI components.”
Public comment is encouraged within 90 days. “In particular, the FDA is asking for feedback on how well this draft guidance aligns with industry experience and whether the options available for sponsors and other interested parties to engage with the FDA on the use of AI are sufficient. The agency will review and consider comments received before finalizing this guidance.”
