CDER lead­ers ready to im­ple­ment swifter ac­cel­er­at­ed ap­proval with­draw­al process

With the long Mak­e­na ac­cel­er­at­ed ap­proval with­draw­al saga fresh in their minds, both the di­rec­tor of the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) and her deputy dis­cussed up­com­ing guid­ance on how these with­drawals will move more quick­ly.

Thanks to the Food and Drug Om­nibus Re­form Act (FDO­RA), FDA has new au­thor­i­ty to not on­ly re­quire con­fir­ma­to­ry tri­als to be­gin pri­or to an ac­cel­er­at­ed ap­proval but al­so has Con­gress’ bless­ing to speed up the with­draw­al process when a con­fir­ma­to­ry tri­al does not show clin­i­cal ben­e­fit.

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