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- FDA’s AI push faces uncertainty after key leaders departThe FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…
- Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selectionIndustry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…