Regulatory Evolution: Navigating the FDA’s 2025 Modernization

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2025-12-17 12:34:25 -

In 2025, the FDA has fully implemented its multi-year modernization initiative, introducing new standards for data integrity and clinical trial diversity. These regulations require sponsors to provide "Diversity Action Plans" before a trial begins, ensuring that the participants reflect the diverse demographic makeup of the US population. Additionally, there is a heightened focus on the use of...

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