FDA lead­ers Califf and Paz­dur dish on ac­cel­er­at­ed ap­proval re­forms, sin­gle-coun­try tri­als and an emp­ty White Oak

FDA Com­mis­sion­er Rob Califf sat down for a con­ver­sa­tion on Thurs­day morn­ing with Rick Paz­dur, head of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, with the two agree­ing that ac­cel­er­at­ed ap­proval re­forms need to hap­pen, that mul­ti-re­gion­al clin­i­cal tri­als are al­ways bet­ter than sin­gle-coun­try tri­als, and that re­turn­ing every last FDAer to the White Oak cam­pus doesn’t make sense.

The con­ver­sa­tion, con­duct­ed as part of the Friends of Can­cer Re­search’s an­nu­al meet­ing, be­gan with Califf’s ques­tions on the emp­ty space around White Oak as rou­tine staff have most­ly moved their op­er­a­tions to the more ver­sa­tile vir­tu­al set­ting, and as ad­vi­so­ry com­mit­tee and all in­dus­try meet­ings re­main vir­tu­al.

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