News & Analysis as of May 25, 2025

Biologics

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FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on 1/23/2025

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Emery on 6/20/2024

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

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Machine Learning › Healthcare › Biologics

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

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