FDA com­mis­sion­er on ac­cel­er­at­ed ap­proval re­forms: 'Need to ad­dress as soon as pos­si­ble'

As Con­gress punt­ed the user fee rid­ers on ac­cel­er­at­ed ap­proval path­way re­forms, FDA com­mis­sion­er Rob Califf made clear at a con­fer­ence this week that such re­forms need to hap­pen “as soon as pos­si­ble.”

The com­ment, com­ing near the end of a speech Califf made Mon­day at the Na­tion­al Or­ga­ni­za­tion for Rare Dis­or­ders’ an­nu­al con­fer­ence, fol­lowed sim­i­lar sug­ges­tions for re­forms as of­fi­cials at the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, who took to the NE­JM late last month ar­gu­ing for im­prove­ments to the agency’s abil­i­ty to ex­pe­di­tious­ly pull dan­gling ac­cel­er­at­ed ap­provals, which oc­cur when, on the rare oc­ca­sion, con­fir­ma­to­ry tri­als fail, but al­so bet­ter build­ing “qual­i­ty and ef­fi­cien­cy in­to the AA on-ramp.”

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