PDUFA (Prescription Drug User Fee Act)

The Prescription Drug User Fee Act (PDUFA), enacted in 1992, allows the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies when they submit new drug applications. These fees help accelerate the drug approval process by providing the FDA with additional resources. This means new medications can be reviewed and potentially reach patients more quickly, while still maintaining safety and effectiveness standards. PDUFA has been reauthorized multiple times to adapt to changing needs and has played a significant role in enhancing the efficiency of drug development and review.