Prescription Drug User Fee Act Amendments (PDUFA VI)

The Prescription Drug User Fee Act Amendments (PDUFA VI) is a law that allows the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies to fund the review of new drug applications. This helps the FDA process and approve new medicines more quickly while maintaining safety and effectiveness. PDUFA VI, enacted in 2017, extends these funding mechanisms and includes goals for faster drug reviews, enhanced science, and increased transparency, ultimately aiming to get safe, effective medicines to patients more efficiently.