Hannah Anderson

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Machine Learning

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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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more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FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

1/13/2025 / Artificial Intelligence , Data Management , Data Privacy , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Regulatory Requirements , Risk Management

Bipartisan Senate Group Releases Long-Awaited ‘Roadmap’ for AI’s Legislation and Regulation

Not to be left out of the international discourse on AI, on May 15, 2024, a bipartisan group of U.S. senators released a long-awaited “roadmap” for AI, detailing areas the Senate considers ripe for legislation and regulation....more

5/22/2024 / Algorithms , Artificial Intelligence , Innovative Technology , Machine Learning

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

10/7/2022 / Artificial Intelligence , Food and Drug Administration (FDA) , Innovation , Innovative Technology , Machine Learning , Medical Devices , NIST , Prescription Drugs , Regulatory Agenda , Regulatory Standards

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