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FDA and EMA Align on Ten Principles to Guide Artificial Intelligence Use in Drug Development
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New Phase II Data Suggest Maternal Nipocalimab Does Not Disrupt Infant Immune Development in Severe HDFN
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Slower FDA Guidance Pushes Sponsors Toward Legacy Approaches
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ACT Brief: FDA Capacity Strains Timelines, Sponsors Rethink Site Support, and Regulators Align on AI
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