FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what ex­act­ly will be in­clud­ed in the third it­er­a­tion of Biosim­i­lar User Fee Act (Bs­U­FA) from 2023 through 2027, which sim­i­lar­ly to the pre­scrip­tion drug deal, sets fees that in­dus­try has to pay for sub­mit­ting ap­pli­ca­tions, in ex­change for firm time­lines that the agency must meet.

This lat­est deal in­cludes sev­er­al sweet­en­ers for the biosim­i­lar in­dus­try, which has yet to make great strides in the US mar­ket, with short­er re­view time­lines for safe­ty la­bel­ing up­dates and up­dates to add or re­move an in­di­ca­tion that does not con­tain ef­fi­ca­cy da­ta.

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