Es­hoo calls out FDA for miss­ing dead­line on di­ver­si­ty ac­tion plan guid­ance

Rep. An­na Es­hoo (D-CA) called out the FDA for hav­ing yet to pub­lish guid­ance for in­dus­try on draft­ing di­ver­si­ty ac­tion plans for clin­i­cal tri­als dur­ing a Friends of Can­cer Re­search vir­tu­al meet­ing Thurs­day.

In open­ing re­marks, Es­hoo, who chairs the House En­er­gy and Com­merce health sub­com­mit­tee and is re­tir­ing at the end of this term, flagged that the FDA has missed its dead­line to is­sue or re­vise its di­ver­si­ty ac­tion plans, and vowed to hold the agency ac­count­able to com­ply with the law. Un­der the Food and Drug Om­nibus Re­port Act (FDO­RA) of 2022, the FDA was man­dat­ed to re­vise or is­sue this guid­ance by the end of 2023 but still has yet to do so.

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