Ac­cel­er­at­ed ap­proval re­forms take cen­ter stage at House hear­ing, but a way for­ward re­mains un­clear

The House En­er­gy & Com­merce com­mit­tee’s health sub­com­mit­tee on Thurs­day dug in­to al­most two dozen dif­fer­ent FDA- and phar­ma-re­lat­ed bills that may be tacked on­to a larg­er bill or even the bio­phar­ma user fee bills, which have to be reau­tho­rized be­fore the end of Sep­tem­ber.

The mas­sive batch of bills mak­ing their way through the House in­cludes two crit­i­cal bills that seek to re­form the FDA’s ac­cel­er­at­ed ap­proval process in dif­fer­ent ways.

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