Joy Sharp

Joy Sharp

Faegre Drinker Biddle & Reath LLP

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FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more

1/20/2025  /  Artificial Intelligence , Biopharmaceutical , Compliance , Data Management , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Pharmaceutical Industry , Risk Management

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

1/13/2025  /  Artificial Intelligence , Data Management , Data Privacy , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Regulatory Requirements , Risk Management
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