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Amendments and Requests for Final Approval to Tentatively Approved ANDAs | FDA Guidance for Industry

This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. 

This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (“earliest lawful ANDA approval date”).

This guidance replaces the final guidance of the same title issued in September 2020.  This guidance is being issued to incorporate the performance goals currently outlined in the GDUFA2.

Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter), and it describes how FDA will handle requests for final approval and amendments to tentatively approved ANDAs subject to the performance goals in the GDUFAIII commitment letter. 

It also contains clarifying revisions to section II.B concerning patent certifications and exclusivities and their effect on timing of ANDA approval.

The Generic
Drug User Fee Amendments of 2012 GDUFA I) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect user fees to provide the Agency with resources to help ensure patients have access to quality, safe, and effective genericdrugs.

GDUFA fee resources bring greater predictability and timeliness to the review of generic drug applications. GDUFA has been reauthorized every 5 years to continue FDA’s ability to assess and collect GDUFA fees, and this user fee program has been reauthorized two times since GDUFA I, most recently in the Generic Drug User Fee Amendments of 2022.

As described in the GDUFA III commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals and program enhancements regarding aspects of the generic drug assessment program that build on previous authorizations of GDUFA. New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent of reducing the number of assessment cycles for ANDAs and facilitating timely access to generic medicines for American patients.

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