FDA revised guidance for industry titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.”

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This updated guidance outlines how the assessment goals established by the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments made to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) submitted to the FDA. It also provides detailed information on the classification of amendments and how these classifications can impact the assessment goal dates for applications. This replaces the July 2018 guidance for ANDA Amendments under GDUFA. According to the FDA, every submission to an application under assessment is considered an amendment. These submissions are classified based on the submitted content, with goal dates assigned according to the classification and other criteria specified in the GDUFA III Commitment Letter. The guidance details the types of amendments and assessment goals relevant only to submissions that are undergoing substantive assessment. Key Elements of FDA’s Amendments Guidance:
  1. Purpose: Clarifies how the GDUFA III goals apply to ANDA amendments and supplements.
  2. Amendment Types: Defines major, minor, and unsolicited amendments.
  3. Assessment Goals: Determines amendment review timelines based on priority, complexity, and inspection needs.
  4. Appendix A: Lists examples of major deficiencies (quality, bioequivalence, labeling) and the process to resolve them.
  5. Revisions: Updated guidance reflects public comments and GDUFA III commitments, removing outdated sections and examples.
Purpose of Changes: Incorporate GDUFA III Commitments: Update amendment classifications and improve review consistency through internal FDA training.  
Comparison of July 2018 and September 2024 – ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA
July 2018 Generics September 2024 Generic Drugs Revision 1
Background: GDUFA II (Oct 2017) Background: GDUFA III (Oct 2022) FDA made minor updates to the guidance to reflect the GDUFA III commitment letter and legislation
C. Amendments to ANDAs and PASs Submitted Prior To and During GDUFA I Removed Two outdated sections were removed. The two outdated sections referenced target action dates and GDUFA I submissions, which are no longer applicable under GDUFA III.Submission Type Standard major amendment to a PAS Priority major amendment to a PAS Standard or priority minor amendment to a PAS Table 2: Summary of Performance Goals to Major and Minor Amendments to PASs Submission TypeStandard PASPriority PAS Standard PAS major amendments Priority PAS major amendments Standard or priority minor PAS amendments
APPENDIX B: Excerpted Text from Guidance For Industry, Major Minor, And Telephone Amendments To Abbreviated New Drug Removed Appendix B contained an older iteration of this guidance that has been superseded
In the content the guidance previously referred to as ‘review’ Language change from ‘review’ to ‘assessment’ in the new version.”
Section IV sub section A “Amendments to ANDAs” Changed Section IV sub section A to  “Amendments to  original ANDAs”
For complete details on the updated guidelines, click on the link: https://www.fda.gov/media/89258/download
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