FDA fi­nal­izes CAR-T and gene ther­a­py guid­ance, of­fers sup­port for ac­cel­er­at­ed ap­provals

The FDA on Mon­day fi­nal­ized two guid­ance doc­u­ments to help spon­sors de­vel­op­ing ther­a­pies in two crowd­ed ar­eas: gene ther­a­pies us­ing genome edit­ing and ex vi­vo-man­u­fac­tured CAR-T cell prod­ucts.

The 19-page fi­nal ver­sion of the genome edit­ing guid­ance is clear about the agency’s stance on the use of the ac­cel­er­at­ed ap­proval path­way and now in­cludes a state­ment ex­press­ing the agency’s sup­port, as FDA of­fi­cials like Pe­ter Marks and oth­ers have pre­vi­ous­ly sig­naled:

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