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), and 2007 (PDUFA IV).  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 2009 Clean-Up Product and Establishment Fee Invoices were mailed Wednesday, December 9, 2009. Full payment of the invoice is due in 30 days. If you do not receive your invoice by December 16, 2009, please contact Ashley Jones or Beverly Friedman at 301-796-3602.

• Correction to Prescription Drug User Fee Rates for Fiscal Year 2010 (PDF - 58KB) (Posted 11/13/2009)
  • Establishment of Prescription Drug User Fee Rates for Fiscal Year 2010 (PDF - 61.6 KB) (Posted 8/3/2009)

• FDA has recently been advised that the Wachovia Lockbox address for courier delivery (e.g., UPS, FedEx, DHL) of PDUFA user fee payments has been updated to: 

  Wachovia QLP Lockbox – D1113-022
  Food and Drug Administration, Lockbox 70963
  1525 West WT Harris Blvd
  Charlotte, NC 28262

  FDA has been assured that Wachovia will continue to receive payments at the old address and hopes to be fully transitioned by the end of October.  If you have further questions, please contact Beverly Friedman or Michael Jones 301-796-3602. (Posted 10/9/2009)

  

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

• Establishment of Prescription Drug User Fee Rates for Fiscal Year 2010 (PDF - 61.6 KB) (Posted 8/3/2009)
• User Fee Rates Archive
• PDUFA User Fee Cover Sheet
• Payment Instructions for Applications and Supplements