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Tag Archives: clinical trials

Racial and Ethnic Diversity in Clinical Trials
26 Apr

FDA Update: FDA’s Outlines Racial Diversity for Clinical Trials

Finally it is recognized that racial and ethnic diversity are more than skindeep as the FDA takes important steps to increase diversity in clinical trials. Agency’s Focus on Inclusion in Trials for All Medical Products Aligns with Biden Administration’s Cancer Moonshot Goal of Addressing Inequities and Beyond. The U.S. Food and Drug Administration issued a

22 Apr

Clinical Trials Outside the United States

FDA draft guidance released There are many reasons why a sponsor may want to conduct a clinical trial Outside of the United States (OUS). Question is, will FDA accept this data to support marketing the device in the U.S.? Short answer, yes – provided certain conditions are met. For a PMA, under 21 CFR 814.15(b),

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