PDUFA VI

PDUFA VI refers to the sixth reauthorization of the Prescription Drug User Fee Amendments, a law that allows the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies. These fees help fund the review process of new drug applications, aiming to speed up the time it takes for new medicines to become available while maintaining safety standards. PDUFA VI, enacted in 2017, also emphasizes transparency, communication, and collaboration between the FDA and drug sponsors to improve efficiency and ensure timely access to innovative therapies for patients.