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User Fees / Generics Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision.1) (PDF - 222KB) Draft Guidance 09/09/13
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 - 176KB) Final Guidance 10/14/16
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 - 432KB) Final Guidance 02/12/16
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that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB) Draft Guidance 12/04/14
Generics/User Fees ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA (PDF - 231KB) Draft Guidance 07/10/14
Generics /User Fees ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 214KB) Draft Guidance 06/11/14
Generics / User Fees ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (PDF - 199KB) Final Guidance 12/21/16

Page Last Updated: 06/15/2017
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