FDA User Fees 2012: How Innovation Helps Patients and Jobs

This legislative hearing focused on reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), which expired at the end of September 2012. PDUFA reauthorization will support the approval and expediting of prescription drugs to the marketplace, while the reauthorization of MDUFA and improvements to medical device regulation will help bring greater predictability, consistency, and transparency to the approval of these important medical products. Both PDUFA and MDUFA play important roles in ensuring patients receive quality care and access to new therapies while promoting innovation and job creation.

Hearing Notice

Background Memo

Discussion Draft