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- Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Revised Draft Guidance for Industry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