FDA proposes adding 'race and ethnicity' category to expanded access requests
It’s well understood that racial and ethnic minorities often lack access to clinical trials in the US, either because of restricted inclusion/exclusion criteria or because they don’t have the time, insurance, interest or understanding of what clinical trials are available.
But what about ethnic and racial minorities accessing the FDA’s expanded access program?
That’s what the FDA wants to know, as the agency is now proposing to add an optional item regarding race and ethnicity under the “Clinical Information/Brief Clinical History” field in its form that physicians have to fill out for expanded access requests for individual patient INDs.
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