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August 12, 2022 Regulatory Affairs

FDA Solicits Feedback on ANDA Submissions – Amendments to ANDAs Under GDUFA Guidance, Appendix A


Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for industry entitled “ANDA Submissions–Amendments to Abbreviated New Drug Applications Under GDUFA” (ANDA Amendments Guidance). The agency is soliciting comments on the content of Appendix A to fulfill its commitment described in section IX.B. of the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 Commitment Letter (GDUFA III Commitment Letter).

In the GDUFA III Commitment Letter, FDA agreed to issue a Federal Register notice to solicit public comment on the content of Appendix A in the ANDA Amendments Guidance on or before April 30, 2023. The ANDA Amendments Guidance describes amendment classifications (“major” or “minor” amendments) and categories (amendments subject to “priority” or “standard” review goals) and explains how amendment submission classification and category may affect an amendment’s performance goal date. Appendix A in the ANDA Amendments Guidance is a non-exhaustive list of examples of deficiencies that FDA may consider major.

With this notice, FDA is seeking comments on the examples of major deficiencies listed in Appendix A of the ANDA Amendments Guidance, as well as comments on how any proposed revisions to that list could be beneficial to industry in understanding ANDA amendment classification. For more details, please see the Federal Register notice.

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