Generic Drug User Fee Act (GDUFA)

The Generic Drug User Fee Act (GDUFA) is a U.S. law that requires generic drug manufacturers to pay fees to the Food and Drug Administration (FDA). These fees help fund the review and approval of generic medicines, ensuring they are safe and effective. By providing resources to the FDA, GDUFA speeds up the approval process, making lower-cost generic drugs available to consumers more quickly while maintaining quality standards. It encourages collaboration between industry and regulators to improve the efficiency of generic drug approval without compromising safety.