Abbreviated New Drug Application Submissions-Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA." This guidance finalizes the October 2017 draft guidance for industry "ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA." This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals.