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Center for Biologics Evaluation and Research (CBER) Regulatory Requirements Center for Drug Evaluation and Research (CDER)

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New FDA Guidance on AI and Medical Products

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n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

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