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Make Our Children Healthy Again Assessment: Unpacking the Report

The Trump Administration released its Make Our Children Healthy Again Assessment on May 22, 2025, documenting its rationale for future policy actions related to chronic disease in children. The report focuses on four key...more

“Making America Healthy Again”: The impact on the FDA, life sciences, and healthcare sectors

President Donald Trump recently issued an Executive Order (EO) establishing the President's Make America Healthy Again (MAHA) Commission. The EO, issued on February 13, 2025, addresses a range of issues, including chronic...more

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

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