PDUFA V

PDUFA V refers to the fifth reauthorization of the Prescription Drug User Fee Act, enacted in 2012. It allows the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies to help fund the review and approval process for new drugs. The goal is to speed up access to safe and effective medications while maintaining high standards. PDUFA V included commitments to improve review times, enhance communication between the FDA and drug sponsors, and increase transparency. Overall, it aims to balance timely drug approvals with rigorous safety and efficacy evaluations, benefiting public health.