FDA to Require Diversity Plan for Clinical Trials

February 16, 2023

(Nature) – The US Food and Drug Administration (FDA) will soon require researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants. Many scientists have applauded the move, which was laid out in a spending bill signed into law by US President Joe Biden in December 2022. They say that broadening participant pools is important to make medicines more effective across the whole population. But they are not yet convinced that the FDA will adequately enforce the new requirement. (Read More)