Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Out­side of Covid-19, 2021 has been the year of the ac­cel­er­at­ed ap­proval.

Be­gin­ning last spring, FDA open­ly chal­lenged six “dan­gling” ac­cel­er­at­ed ap­provals (hadn’t con­firmed …

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