Generic Drug User Fee Amendments (GDUFA)

The Generic Drug User Fee Amendments (GDUFA) are laws that allow the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies that produce generic drugs. These fees help fund the FDA's review process, enabling faster approval of generic medications. By ensuring that these drugs meet safety and effectiveness standards, GDUFA aims to promote competition in the pharmaceutical market, leading to lower prices and increased access for consumers. Overall, GDUFA plays a crucial role in balancing public health needs with the efficient processing of generic drug applications.