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FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
The FDA issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety,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. This is the first guidance the agency has issued on the use of AI for the development of drug and biological products.
In developing these recommendations, the FDA 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 Specifically, this draft guidance was informed by feedback from an FDA-sponsored expert workshop convened by the Duke Margolis Institute for Health Policy in Dec. 2022, more than 800 comments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.
The FDA is seeking public comment on the draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, within 90 days. In particular, the FDA is asking for feedback on how well this draft guidance aligns with industry experience and whether the options available for sponsors and other interested parties to engage with the FDA on the use of AI are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.
The FDA’s medical product centers have a shared commitment to promote the responsible and ethical use of AI for medical products. As the field of AI evolves, the agency will continue to develop policies that support innovation and uphold the agency’s rigorous standards for safety and effectiveness.
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