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.
                                                                                                                                 

 

• Information Requests and Discipline Review Letters Under GDUFA
• ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry
• Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
• Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry
• ANDA Submissions - Refuse-to-Receive Standards: : Questions and Answers Guidance for Industry
• Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments
• Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry
• ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits
• Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry
• Controlled Correspondence Related to Generic Drug Development
• How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD
• ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA
• ANDA Submissions — Content and Format of Abbreviated New Drug Applications
• ANDA Submissions – Prior Approval Supplements Under GDUFA
• Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry
• Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
• Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry
• Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Revised Draft Guidance for Industry

 

GDUFA MAPPs

• Communications with Industry with respect to Pre-GDUFA Year Three Abbreviated New Drug Applications
• Prioritization of the Review of Original ANDAs, Amendments, and Supplements
• Filing Review of Abbreviated New Drug Applications
• Communicating Certain Deficiencies Identified During Filing Review of ANDAs
• Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA
• Communicating Abbreviated New Drug Application Review Status Updates with Industry
• Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications