House Democrats reiterate call for FDA to work on clinical diversity action plans

De­moc­rats on the House En­er­gy and Com­merce com­mit­tee on Tues­day sent a let­ter to FDA com­mis­sion­er Rob Califf re­quest­ing the agency give in­dus­try more guid­ance on mak­ing clin­i­cal tri­als more di­verse and in­clu­sive.

The guid­ance is tied to the Food and Drug Om­nibus Re­form Act of 2022 (FDO­RA), which re­quires phar­ma com­pa­nies to sub­mit di­ver­si­ty ac­tion plans to the FDA ahead of piv­otal tri­als. But the leg­is­la­tors say the agency has yet to com­ply with the law’s re­quire­ment that the FDA pub­lish draft guid­ance on the for­mat and con­tent of the plans no lat­er than Dec. 29, 2023.

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