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October 21, 2022

Congress Authorizes GDUFA III

On September 30, Congress reauthorized the Generic Drug User Fee Amendments (GDUFA), making the provisions effective from October 1, 2022 through September 30, 2027. Originally enacted in 2012, the GDUFA authorizes the FDA to collect fees from industry users to support review of applications for generic drugs.  In conjunction with this reauthorization, FDA issued guidance for ANDA Submissions—Prior Approval Supplements Under GDUFA, which updated the previous guidance issued five years ago on submitting applications for prior approval supplements (PASs) and PASs amendments for abbreviated new drug applications (ANDAs). According to FDA, the guidance is meant to describe the relationship between GDUFA and PAS submissions. The guidance also “incorporate[s] the performance goals currently outlined in the GDUFA . . . that FDA has agreed to meet . . . .” 

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