What is PDUFA?

  • Share:

WHAT IS PDUFA?

Do you ever wonder what PDUFA stands for?

You are not alone. Put simply, the Prescription Drug User Fee Act (PDUFA) mandates metrics for FDA to review and approve/reject marketing applications within 10 months.

In exchange for reviewing drug and biologic license applications within timelines, the agency collects fees from industry. It is reauthorized every 5 years with enhancements. Adding to the confusion, regulatory professionals refer to reauthorizations by the reauthorization number (PDUFA V), the congressional act in which it was reauthorized (The FDA Safety and Innovation Act), or the acronym for the congressional act (FDASIA). The table below demystifies the competing terminology for this simple concept:

PDUFA Authorization Number Year Name Of Act
PDUFA I 1992 The Prescription Drug User Fee Act (PDUFA)
PDUFA II 1997 The FDA Modernization Act (FDAMA)
PDUFA III 2002 The Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPRA)
PDUFA IV 2007 The FDA Amendments Act (FDAAA)
PDUFA V 2012 The FDA Safety and Innovation Act (FDASIA)
PDUFA VI 2017 The FDA Reauthorization Act (FDARA)
PDUFA VII 2022 The FDA User Fee Reauthorization Act

 

  • Share:

Contact Us

Let’s Get Started

Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.

1.877.787.0177

22320 Foothill Blvd. Suite 330, Hayward CA 94541