Prescription Drug User Fee Act (PDUFA)

The Prescription Drug User Fee Act (PDUFA) is U.S. legislation that allows the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies when they submit new drug applications. These fees help speed up the review process, enabling the FDA to hire more staff and reduce waiting times for drug approvals. Established in 1992, PDUFA aims to ensure that safe and effective medications reach patients more quickly while maintaining rigorous standards for drug evaluation. The act is regularly reauthorized, reflecting its importance in improving public health and access to innovative therapies.