How Will AI Use in Biomanufacturing Be Regulated?
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How Will AI Use in Biomanufacturing Be Regulated?
Drug industry regulators are embracing AI to streamline their oversight activities; however, say researchers, they are yet to make clear how they will regulate the use of the technology in manufacturing. In June, the FDA launched a generative AI tool—Elsa—to help scientific reviewers, investigators, and other staff work more efficiently. The agency also signaled its intention to integrate more AI into different regulatory processes. Likewise, on…
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