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FDA Voices Insights from FDA leadership and experts into the agency's work to protect public health.
FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule
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.

These clinical trials are only possible because of the people who volunteer to participate to help find new products to treat, prevent, or diagnose specific medical conditions. The FDA is committed to protecting clinical trial participants and helping to ensure that the clinical research enterprise welcomes a breadth of participants who receive relevant and accessible information about participating. It is with these goals in mind that we approach the modernization of the FDA’s oversight of clinical research and harmonizing with the U.S. Department of Health and Human Service (HHS) Common Rule to make clinical trials more efficient and improve information for potential participants. The Common Rule is a set of federal rules that protect people who participate in research.

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