The Generic Drug User Fee Act is a law designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry.

• Up until October 2012, the law only required user fees for firms submitting new drug applications (NDAs).
• As of October 1, 2012, under GDUFA, all firms that manufacture human generic drug products, and active ingredients for human generic drug products, that are distributed in U.S. commerce are subject to FDA user fees.
• GDUFA fees will increase the ability of the Agency to perform critical program functions and to reduce costs considering the reduced review timelines.