While the FDA’s diligence in developing guidance on trial diversity can strengthen trust and collaboration among regulators, the pharmaceutical industry, and potential participants, there’s ...

Six months after its due date, the FDA’s draft guidance for clinical trial diversity is finally here. The agency on June 26 issued a new outline of its proposed requirements for the racial and ...

The FDA's removal of draft guidance on clinical trial diversity raises concerns about its commitment to diversity and compliance with statutory obligations. The draft guidance aimed to improve the ...

This initiative, known as the FDA's Diversity Action Plan (DAP), will require ... they might be particularly useful for translating trial data to patient care, she added. Harvey reported financial ...

The FDA's Diversity Action Plan draft guidance to drug ... people from diverse populations for every late-stage clinical trial slated for U.S. regulatory review. It was due to be finalized by ...

The removal of pages linking to diversity ... (FDA’s) and National Institute of Health (NIH) websites covering diversity were ...

Former FDA leader Janet Woodcock, M.D., is also on the CTAC’s board, along with Big Pharma vet Freda Lewis-Hall, M.D., who most recently spent 11 years at Pfizer. The CTAC spent its trial period ...

The Food and Drug Administration has removed webpages about diversity and inclusion ... that's serious." FDA efforts to improve clinical trial equity and inclusion went beyond race and sex ...

Bhatt said he was optimistic that the release of this FDA guidance will increase diversity in clinical trials moving forward, noting, however, that some of the measures needed to enhance diversity can ...

The FDA said the goals for a study, or the "diversity action plan", should be set keeping in mind the estimated prevalence of a disease for which the drug or device is being evaluated.