For Industry

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 Guidances

CategoryTitleTypeDate
Generics / User fees Information Requests and Discipline Review Letters Under GDUFA  (PDF - 81KB) Draft Guidance 12/15/17
Generics - User Fees Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry (PDF - 154KB) Draft Guidance 10/02/17
User Fees / Generics 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 (PDF - 131KB) Final Guidance 07/25/17
Generics - User Fees ANDA Submissions - Refuse-to-Receive Standards: : Questions and Answers Guidance for Industry (PDF - 153KB) Draft Guidance 10/02/17
User Fees /Generics Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments (PDF - 222KB) Final Guidance 11/21/16
Generics / User Fees Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry (PDF - 268KB) Final Guidance 09/22/16
Generics /User Fees ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits (PDF - 326KB) Final Guidance 08/24/16
Generics/User Fees/ Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 379KB) Final Guidance 10/04/17
Generics/User Fees Controlled Correspondence Related to Generic Drug Development (PDF - 379KB) Final Guidance 09/28/15
Generics /User Fees How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB) Draft Guidance 12/04/14
Generics/User Fees ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA (PDF - 219KB) Final Guidance 07/03/18
Generics /User Fees ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 308KB) Final Guidance 09/24/18
Generics / User Fees ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 147KB) Final Guidance 10/04/17
Generics - User Fees Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry (PDF - 99KB) Draft Guidance 10/11/17
Generics / User Fees Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA October 2017 (PDF - 94KB) Draft Guidance 10/13/17
Generics - User Fees Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry (PDF - 171KB) Draft Guidance 11/02/17
Generic - User Fees Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 DRAFT Guidance for Industry (PDF - 316KB) Draft Guidance 10/01/17

GDUFA MAPPs

CategoryTitleTypeDate
5240.3 Rev.4 Prioritization of the Review of Original ANDAs, Amendments, and Supplements (PDF - 112KB) Office of Generic Drugs 11/09/17
5200.14 Filing Review of Abbreviated New Drug Applications (PDF - 521KB) Office of Generic Drugs 09/01/17
5220.3 Communicating Certain Deficiencies Identified During Filing Review of ANDAs (PDF - 70KB) Office of Generic Drugs 09/28/17
5220.1 Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA (PDF - 61KB) Office of Generic Drugs 10/04/17
5200.12 Communicating Abbreviated New Drug Application Review Status Updates with Industry (PDF - 99KB) Office of Generic Drugs 10/06/17
5220.5 Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications (PDF - 86KB) Office of Generic Drugs 12/15/17

Page Last Updated: 04/10/2018
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