Prescription Drug User Fee Act Amendments

The Prescription Drug User Fee Act Amendments (PDUFA) are laws that allow the U.S. Food and Drug Administration (FDA) to collect fees from drug manufacturers when they submit new medications for approval. These fees help the FDA enhance its review processes, ensuring that new drugs are evaluated thoroughly and efficiently. The amendments aim to improve the speed and quality of drug approvals while maintaining safety standards. By funding these operations, PDUFA helps streamline access to new treatments for patients, promoting public health outcomes.