On October 28, 2016, 1 PM, ET, CDER will host a LIVE webinar titled: "Overview of GDUFA II and Implementation of GDUFA II User Fees".
This webinar will provide a brief overview of changes to the user fee structure under GDUFA II and what it means for regulated industry. We will discuss those changes to the user fee structure under GDUFA II and describe how CDER and Industry can best prepare for GDUFA II go-live on October 1, 2017.
Featured Speakers include:
Donal Parks, Director, Division of User Fee Management and Budget Formulation
Gisa Perez, Branch Chief, Generics, Division of User Fee Management and Budget Formulation
This webinar has been pre-approved by RAPS as eligible for up to 1 credit towards a participant's RAC recertification upon full completion.
GDUFA, an historic first: Providing user fees for FDA to ensure timely review of applications for generic drugs
The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.
GDUFA is designed to build on the success of the Prescription Drug User Fee Act (PDUFA). Over the past 20 years, PDUFA has ensured a more predictable, consistent, and streamlined premarket program for industry and helped speed access to new, safe and effective prescription drugs for patients. GDUFA will also enhance global supply chain safety by requiring that generic drug facilities and sites around the world self-identify.
The current legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. More information on recent developments related to the reauthorization of GDUFA is available at the GDUFA Reauthorization Website.
FY17 GDUFA Fees Table
On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This new law includes the Generic Drug User Fee Amendments of 2012 (GDUFA) which is designed to speed access to safe and effective generic drugs to the public. GDUFA authorizes the Food and Drug Administration (FDA) to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities.
- Generic Drug User Fee Amendments of 2012; Pub. L. 112-144, Title III
- FDA User Fee Corrections Act of 2012 signed into law Oct. 5, 2012 to enable collection of FY 2013 GDUFA user fees without enactment of an appropriations Act
- GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDF - 99KB)
User Fee Lists
Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016. FY 2017 GDUFA Facility Fee Cover Sheets are now available in the User Fee System for FY 2017 facility payments.
Generic Drug User Fee Cover Sheet and Payment Information Generic Drug Facilities, Sites and Organization Lists
- FY 2017: Self-Identified Generic Drug Facilities, Sites and Organizations (XLS - 1.9MB)
GDUFA Facility Arrears List(PDF - 113KB)
GDUFA Facilities with Outstanding Fees Not on the Arrears List(XLSX - 344KB)
- Type II Drug Master Files - Available for Reference List (XLS - 487KB)
- GDUFA Backlog Arrears List (PDF - 10KB)
Self-Identification of Generic Drug Facilities, Sites and Organizations
Fiscal year 2017 reporting period for self-identification opens May 1st to June 1st of 2016
- Self-Identified Generic Drug Facilities, Sites and Organizations
Frequently Asked Questions
- FY 2016: Self-Identified Generic Drug Facilities, Sites and Organizations (XLS - 787KB)
FY 2015: Self-Identified Generic Drug Facilities, Sites and Organizations(XLS - 1.9MB)
- FY 2014: Self-Identified Generic Drug Facilities, Sites and Organizations List (XLS - 1.8MB)
FY 2013: Self-Identified Generic Drug Facilities, Sites and Organizations List(XLS - 2.7MB)
- Technical Walk-Through and Live Question and Answer Session [ARCHIVED]
11/19/2012 and 11/20/2012
- Overview and Technical Walk-Through of Self-Identification Process