PDU­FA VII to ex­pand FDA’s re­al-time on­col­o­gy re­views to sup­ple­ments for all ther­a­peu­tic ar­eas

The FDA’s pop­u­lar pro­gram to speed up its re­views of new on­col­o­gy drugs and sup­ple­men­tal ap­pli­ca­tions by months will be ex­pand­ed in­to a larg­er pro­gram for ef­fi­ca­cy sup­ple­ments across all ther­a­peu­tic ar­eas.

The new pro­gram, to be known as Split Re­al-Time Ap­pli­ca­tion Re­view (STAR), first came to light in the min­utes of a De­cem­ber meet­ing of the pre­mar­ket sub­group work­ing on the ne­go­ti­a­tion of the lat­est it­er­a­tion of the Pre­scrip­tion Drug User Fee Act (PDU­FA VII).

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