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Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

FDA Law Blog

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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What does the FDA animal testing legislation mean for drug discovery? 

Drug Discovery World

ends a federal mandate that experimental drugs need to be tested on animals before they can be used in human clinical trials 2. As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. The Modernization Act 2.0

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