GDUFA Guidances and MaPPs
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 â 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 â 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 â Amendments and Easily Correctable Deficiencies Under GDUFA
- ANDA Submissions â Content and Format of Abbreviated New Drug Applications
- ANDA Submissions â 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- Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 DRAFT Guidance for Industry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