Few­er than 40% of new ac­cel­er­at­ed ap­provals demon­strate 'high' ther­a­peu­tic val­ue, study says

As Con­gress con­tin­ues to mull whether and how to re­form the FDA’s ac­cel­er­at­ed ap­proval path­way, new re­search on the path­way con­tin­ues to crop up, at­tempt­ing to guide the way for new re­forms.

Ear­li­er this week, sev­er­al promi­nent re­searchers from Har­vard, UPenn and the Brook­ings In­sti­tu­tion called for new fi­nan­cial in­cen­tives to en­cour­age com­pa­nies to fin­ish the tri­als nec­es­sary to con­vert ac­cel­er­at­ed ap­provals to full ap­provals, or at least re­form how com­pa­nies are paid af­ter win­ning an ac­cel­er­at­ed ap­proval.

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