For Industry
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 Dear Colleague Letter (PDF - 449KB), in anticipation of FY 2011 Invoices, was mailed Wednesday, May 5, 2010. If you do not receive the letter by May 19, 2010, please contact Ashley Jones or Beverly Friedman at 301-796-3602. |
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 - 61.6KB) (Posted 8/3/2009)
- Correction to Prescription Drug User Fee Rates for Fiscal Year 2010 (PDF - 58KB) (Posted 11/13/2009)
- User Fee Rates Archive
- PDUFA User Fee Cover Sheet
- Payment Instructions for Applications and Supplements