Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) is a U.S. law that allows the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies when they submit new drug applications for approval. These fees help expedite the review process, enabling faster access to new medications for patients. Enacted in 1992, the act aims to improve the efficiency and effectiveness of the drug approval process while ensuring safety and efficacy. It has been reauthorized several times, reflecting its importance in balancing timely drug availability with regulatory oversight.