New drug ap­pli­ca­tion fil­ings with FDA to cost more than $3M for first time ever in 2022

For the first time ever, bio­phar­ma com­pa­nies fil­ing new drug ap­pli­ca­tions in 2022 with clin­i­cal da­ta will have to pay the FDA more than $3 mil­lion per ap­pli­ca­tion.

The PDU­FA fee for such a fil­ing is ne­go­ti­at­ed in five-year blocks of time — the next round of PDU­FA ne­go­ti­a­tions, cov­er­ing 2023 to 2027, just wrapped up. The fees are paid to en­sure the FDA re­sponds to the vast ma­jor­i­ty of ap­pli­ca­tions by 10 months for a stan­dard re­view, or six months for an ex­pe­dit­ed one.

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