Hospital & Healthcare Management April 18, 2022
The US Food and Drug Administration today issued a new draft guidance to industry for formulating plans to register more people from underrepresented races and ethnicities in clinical trials in the United States, building on the agency’s earlier recommendations for improving clinical trial diversity.
As the United States’ population grows more diverse, assuring meaningful participation of racial and ethnic minorities throughout clinical trials for authorised medical products is critical to public health, said Robert M. Califf, M.D., the FDA Commissioner. Attaining a broader spectrum will be a significant emphasis for the FDA going forward in order to support the implementation of improved therapies and ways to combat diseases that disproportionately affect various communities. This guidance also demonstrates how they support...
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