Drugs

User Fees

Below is a sortable listing of User Fees Guidances

Category	Title	Type	Date
User Fees	User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 287KB)	Final Guidance	09/26/11
Modernization Act; User Fees	Classifying Resubmissions in Response to Action Letters. (PDF - 76KB)	Final Guidance	05/14/98
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