Generic Drug User Fee Act

The Generic Drug User Fee Act (GDUFA) is a law that requires generic drug manufacturers to pay fees to the U.S. Food and Drug Administration (FDA). These fees help fund the review and approval process for generic medications, ensuring they are safe, effective, and available more quickly. In return, the FDA can dedicate more resources to efficiently evaluate generics, reducing delays and keeping prices lower for consumers. Overall, GDUFA promotes a faster, predictable process for bringing affordable, high-quality generic drugs to market.