For Industry

Generic Drug User Fee Amendments of 2012

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.

FY16 GDUFA Fees Table

ANDA $76,030
PAS $38,020
DMF $42,170
Facility Domestic API $40,867
Foreign API $55,867
Domestic FDF $243,905
Foreign FDF $258,905
Backlog N/A

 

GDUFA Legislation

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.

Page Last Updated: 07/26/2016
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