GDUFA Guidances and MAPPs
This page provides quick access to guidances for industry and sections of the FDA Manual of Policies and Procedures (MAPP) related to GDUFA.
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 the Review of Original ANDAs, Amendments, and Supplements (January 2020)
- Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications (December 2017)
- Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA (October 2017)
- Communicating Abbreviated New Drug Application Review Status Updates with Industry (October 2017)
- Filing Review of Abbreviated New Drug Applications (September 2017)
- Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (September 2017)
- Communicating Certain Deficiencies Identified During Filing Review of ANDAs (September 2017)