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 2010 Product and Establishment Fee Invoices were mailed Friday, August 14, 2009.  Full payment of the invoice is due by October 1, 2009.  If you do not receive your invoice by August 24, 2009, please contact Michael Jones or Beverly Friedman at 301-796-3602. (Posted 8/18/2009)

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

  

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