Prescription Drug User Fee Act (PDUFA)

The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V).  It authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

News 

The FY 2013 Product and Establishment Fee Invoices were mailed Wednesday, August 15, 2012. Full payment of the invoice is due October 1, 2012. If you do not receive your invoice by August 27, 2012, please contact Ashley Jones or Beverly Friedman at 301-796-3602. (posted 8/16/2012) Establishment of Prescription Drug User Fee Rates for Fiscal Year 2013 (PDF - 214KB) (posted 8/1/2012) Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 287KB) [Federal Register Notice (PDF - 144KB)] (posted 9/27/2011)  Please note that there has been a change in the address for submission of waivers, refunds, and reductions (see pages 16-18 of the Guidance). The new room number is 6288. (posted 3/2/2012)

 

User Fees and Forms

This site provides information on various user fee-related issues.  If you have questions about user fees, you can contact either Ms. Beverly Friedman or Mr. Michael Jones at 301-796-3602.  Mailing address and other contact information.

• Payment instructions for applications and supplements, effective 2/24/2011 (posted 2/24/2011)
• Establishment of Prescription Drug User Fee Rates for Fiscal Year 2013 (PDF - 214KB) (posted 8/1/2012)
  
• User Fee Rates Archive
• PDUFA User Fee Cover Sheet