FDA clinical trial diversity policies in limbo

The Trump administration’s campaign against diversity, equity, inclusion and accessibility programs continues to impact FDA and generate uncertainty for drug developers and patient advocates.

Draft guidance on clinical trial diversity plans has been removed from FDA’s website and agency staff told BioCentury it isn’t clear if it will be reinstated. In the absence of a final guidance, which FDA was slated to issue this summer, the agency may not have the legal authority to require clinical trial diversity plans. ...