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FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions

The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality.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

U.S. States Begin Regulating Generative Artificial Intelligence in Health Care

The health care industry has utilized artificial intelligence for decades, but the recent expansion of AI’s capabilities into generative AI models is raising questions about how and to what extent to regulate the technology....more

Generative AI and Health Care: Key Takeaways

Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more

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