Generic Drug User Fee Amendments of 2012

GDUFA, a 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.