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FDA Further Harmonizing Clinical Research Regulations with HHS Common Rule

October 11, 2022

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Clinical trials play a crucial role in advancing science and supporting the development of new medical products to address unmet patient needs. Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical to the U.S. Food and Drug Administration’s decision-making about a product’s benefits and risks. In general, clinical trials, particularly advanced stage trials, that enroll participants reflecting the diversity of patient populations will help make it possible to apply the findings from clinical trials to broader patient populations and maximize the public health impact of FDA cleared or approved products.

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