FDA: ANDA Guidance for Industry published

In September 2024, the U.S. FDA published the Guidance for Industry 'Amendments to Abbreviated New Drug Applications Under GDUFA' in Revision 1.

This describes how amendments can be made by applicants for ANDAs (Abbreviated New Drug Applications) and PASs (Prior Approval Supplements). For this purpose, the amendments are divided into different categories, which can already be seen in the table of contents of the guideline:

I. INTRODUCTION
II. BACKGROUND
III. CATEGORIES OF GDUFA AMENDMENTS
  A. Major Amendments
  B. Minor Amendments
  C. Unsolicited Amendments
IV. ASSESSMENT GOALS
  A. Amendments to Original ANDAs
    1. Major Amendments
    2. Minor Amendments
    3. Unsolicited Amendments
  B. Amendments to PASs
    1. Major Amendments
    2. Minor Amendments
    3. Unsolicited Amendments
V. APPLICATION OF ASSESSMENT GOALS
  A. Changes to Classifications or Assessment Goals
  B. Deferred Amendments
  C. Amendments Submitted to Tentatively Approved Applications
    1. Requests for Final Approval
    2. Amendments Other Than Requests for Final Approval
  D. Amendments Submitted in Response to Changes in the Drug Master File
VI. SUBMISSION AND RECEIPT OF AMENDMENTS
VII. REQUESTS FOR RECONSIDERATION OF MAJOR AMENDMENT CLASSIFICATION STATUS
APPENDIX A: POTENTIAL MAJOR DEFICIENCIES

Here you can find Revision 1 of the Guidance for Industry 'Amendments to Abbreviated New Drug Applications Under GDUFA' and further explanations regarding the final guidance on the FDA website.