The Prescription Drug User Fee Act (PDUFA) provides the Food and Drug Administration (FDA) with resources to expedite the FDA's review of new medicines, ultimately allowing safe and effective treatments to reach patients faster.
PDUFA is updated, reviewed and approved by Congress every five years. Each version of the bill focuses on different, but equally vital, components of the medicine development and review processes that need attention. Previous versions addressed areas such as review management practices, regulatory science initiatives and product safety. This adaptability makes PDUFA a versatile and incredibly effective opportunity to improve upon current processes.
PDUFA ensures patients have continued access to the breakthrough cures and treatments they deserve and allows the U.S. to continue to lead the world in the discovery and delivery of cutting-edge medicines.