Pocket Card: What Is PDUFA?

Teaser image of PhRMA Pocket Card What is PDUFA

The Prescription Drug User Fee Act (PDUFA) was first enacted in 1992 as a bipartisan solution to increase the efficiency of prescription drug review at the U.S. Food and Drug Administration (FDA). PDUFA has helped the FDA fulfill its central mission — to help protect and advance public health — by allowing the agency to keep pace with the number and complexity of innovative drugs and biologics entering the review pipeline.

Teaser image of PhRMA Pocket Card What is PDUFA