Drugs

User Fees

Below is a sortable listing of User Fees Guidances

CategoryTitleTypeDate
User Fees User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 153KB) Final Guidance 01/06/15
User Fees Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (PDF - 48KB) Final Guidance 06/01/99
Guidance for Industry and FDA Staff - Application User Fees for Combination Products (PDF) Guidance for Industry and FDA Staff - Application User Fees for Combination Products (PDF) (PDF - 83KB) 04/01/05
User Fees Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF - 27KB) Final Guidance 11/01/01
User Fees Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211KB) Final Guidance 12/30/04
User Fees User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (PDF - 46KB) Final Guidance 02/07/07
Compounding/User Fees Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act (PDF - 119KB) Final Guidance 08/03/15
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
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 ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 147KB) Final Guidance 10/04/17
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that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB) Draft Guidance 12/04/14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 -- Refuse-to-Receive Standards Rev.2 (PDF - 199KB) Final Guidance 12/21/16
Generics - User Fees ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry (PDF - 105KB) Draft Guidance 10/02/17
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
Generics - User Fees ANDA Submissions - Refuse-to-Receive Standards: : Questions and Answers Guidance for Industry (PDF - 153KB) Draft Guidance 10/02/17
Generics - User Fees Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry (PDF - 99KB) Draft Guidance 10/11/17
User Fees Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry (PDF - 145KB) Final Guidance 05/02/18
Generics / User Fees Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA October 2017 (PDF - 94KB) Draft Guidance 10/13/17
User Fees / Generics Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (PDF - 708KB) Draft Guidance 10/27/17
Generics - User Fees Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry (PDF - 171KB) Draft Guidance 11/02/17
User Fees Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF - 447KB) Final Guidance 06/28/18
Generics / User fees Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry (PDF - 81KB) Draft Guidance 12/15/17
User Fees Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief (PDF - 332KB) Draft Guidance 06/06/18
User Fees Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry (PDF - 632KB) Draft Guidance 06/20/18

Page Last Updated: 06/20/2018
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