Clinical Trial Diversity Campaign Distracting From Health Equity Problems, Califf Says
The FDA commissioner says that improving health disparities would fix the lack of diversity in clinical trials.
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No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.
With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.
Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.