GDUFA Guidances and MAPPs

GDUFA Guidance for Industry

To view all GDUFA guidances, go to the Guidances for Drugs page, enter “GDUFA” in the search box, and under “Filter by,” choose “Generic Drugs” as the Topic.

GDUFA MAPPs

• Prioritization of Solicited DMF Amendments Associated With ANDAs or PASs not Concurrently Under Assessment (MAPP 5015.14, May 2024)
• Communicating ANDA Review Status Updates with Industry (MAPP 5200.12 Rev. 1, October 2022)
• Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (MAPP 5220.8 Rev.1, October 2022)
• Issuance of Information Requests and/or Discipline Review Letters for ANDAs (MAPP 5220.5 Rev. 2, October 2022)
• Prioritization of the Review of Original ANDAs, Amendments, and Supplements (MAPP 5240.3 Rev. 6, October 2022)
• Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs (MAPP 5210.5 Rev. 3, April 2022)
• Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (MAPP 5230.3 Rev. 1, July 2021)
• ANDA Suitability Petitions (MAPP 5240.5 Rev 2, October 2020)
• Transfer of Ownership (MAPP 5242.1, August 2020)
• Conversion of ANDA Approval to Tentative Approval Because of Court Order (MAPP 5220.2, June 2020)
• ANDA Amendments and Supplements Reviewed by the Division of Filing Review (MAPP 5200.7 Rev 1, April 2020)
• Understanding CDER’s Risk-Based Site Selection Model (MAPP 5014.1, September 2018)
• Good Abbreviated New Drug Application Assessment Practices (MAPP 5241.3, January 2018)
• Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA (MAPP 5220.1, October 2017)
• Filing Review of Abbreviated New Drug Applications (MAPP 5200.14, September 2017)
• Communicating Certain Deficiencies Identified During Filing Review of ANDAs (MAPP 5220.3, September 2017)
• Consolidation of ANDAs by the Office of Generic Drugs (MAPP 5241.2 Rev 1, October 2015)