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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

Artificial Intelligence Briefing: Lawsuits, Agreements and Comments – Oh My!

Recent developments in AI continue to highlight its increasing prevalence and the regulatory challenges it poses. The DOJ has sued RealPage, alleging its AI software enables rent price-fixing, while NIST partnered with OpenAI...more

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

Artificial Intelligence Briefing: New York City Department of Consumer and Worker Protection Ready to Enforce Regulation of...

Our latest briefing dives into new local laws about AI and how it affects both employment and insurance industries, the launch of NIST’s Trustworthy & Responsible Artificial Intelligence Resource Center and the plans for it...more

Artificial Intelligence Briefing: Feds Take Aim at Algorithmic Bias

Our latest briefing examines the latest signal that the Federal Trade Commission is considering rulemaking, a groundbreaking settlement between the Justice Department and Meta over allegedly discriminatory algorithms,...more

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