Bro­ken promis­es? FDA needs more pow­er to re­move drugs from mar­ket­place, JA­MA analy­sis finds

The FDA is strug­gling to re­move drugs from the mar­ket­place that don’t show ef­fec­tive­ness in late stage tri­als, new JA­MA analy­ses found, thanks to the per­sis­tent ten­sion be­tween speed and con­fi­dence in ear­ly clin­i­cal da­ta.

Con­gress, reg­u­lat­ed in­dus­try and pa­tients have urged the FDA to short­en the amount of time that the mar­ket has to wait for drugs to be­come avail­able that may help se­vere and preva­lent dis­eases – and the FDA has lis­tened, of­fer­ing up a quick ac­cel­er­at­ed ap­proval path­way that’s fre­quent­ly used by new can­cer drugs.

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