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Trump Administration’s DEI Executive Order and the Impact on FDA’s DAP Draft Guidance: Top Points

For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...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Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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

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