Creating a 21st century regulatory system is central to ensuring our medicines are safe and effective.

We need a modern regulatory system that supports innovation and the delivery of safe and effective medicines. We must ensure that our regulatory processes are patient-focused, balance benefit and risk, create a predictable framework, and maintain the flexibility to adapt to rapid advances in medical innovation.

The Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) helps the FDA ensure that patients have timely access to breakthrough medicines and that the U.S. continues to be the global leader in delivering these new, lifesaving cures and treatments. During the fifth reauthorization of PDUFA in 2012, we urged legislators to pass a clean and timely PDUFA in order to benefit patients and American innovation.