GDUFA II

GDUFA II (Generic Drug User Fee Amendments II) is a U.S. law that requires generic drug manufacturers to pay fees to the Food and Drug Administration (FDA). These funds help the FDA review and approve generic medications more efficiently, ensuring they meet safety and quality standards. GDUFA II aims to reduce review times, improve transparency, and support the availability of affordable generic drugs. It also encourages continuous industry oversight and enhances compliance, ultimately benefiting public health by ensuring timely access to safe, effective, and affordable generics.