Shari Esfahani

Orrick, Herrington & Sutcliffe LLP

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FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions

The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more

1/17/2025  /  Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices , Pharmaceutical Industry , Risk Management

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

1/8/2025  /  Artificial Intelligence , Bias , Cybersecurity , Data Management , Food and Drug Administration (FDA) , Medical Devices , Regulatory Requirements , Risk Management , Software , Transparency
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