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Life Sciences Center for Biologics Evaluation and Research (CBER) Machine Learning

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

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

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

BakerHostetler on

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

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