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  1. Generic Drug User Fee Amendments

The Generic Drug User Fee Amendments of 2012 (GDUFA) was designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law required industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources enabled FDA to reduce a backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.

On July 9, 2012, GDUFA was signed into law by the President as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). GDUFA must be reauthorized every five years. On September 30, 2022, the President signed the bill reauthorizing GDUFA III through September 30, 2027.

View GDUFA I meeting documents and negotiation session notes in the FDA Archive

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