FDA ex­plains why it de­nied about 60% of non-on­col­o­gy break­through ther­a­py re­quests from 2017 to 2019

The FDA is of­fer­ing a look in­to why it de­nied about 60% of all break­through ther­a­py des­ig­na­tion re­quests it re­ceived from the bio­phar­ma in­dus­try — out­side of on­col­o­gy — be­tween 2017 and 2019, ac­cord­ing to a re­cent analy­sis of BTD ap­provals and de­nials.

CDER of­fi­cials Atasi Pod­dar, Mi­ran­da Rag­gio and John Con­ca­to ex­plained in a pa­per pub­lished last week in Ther­a­peu­tic In­no­va­tion & Reg­u­la­to­ry Sci­ence how 30% were de­nied for a sin­gle rea­son, while 70% were de­nied for mul­ti­ple rea­sons.

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