The 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 develop generic drugs. These fees help expedite the review process, ensuring that safe and effective generic medications reach the market faster. By speeding up approvals, GDUFA aims to increase competition, reduce drug prices, and enhance access to affordable medications for consumers. The program also ensures that the FDA has the resources needed to maintain high standards in the drug approval process.