FDA Hiring Initiative: Generic Drug User Fee Amendments of 2012 (GDUFA)
What is GDUFA?
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. GDUFA is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry.
Industry will now pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.
These additional resources will enable the FDA to reduce a current backlog of pending drug applications, cut the average time required to review them for safety, and increase risk-based inspections.
GDUFA will also enhance global supply chain safety by requiring generic drug facilities/sites worldwide to self-identify and meet FDA standards for safety, purity and effectiveness.