Prescription Drug User Fee Act (PDUFA)
Notice to applicants who owe PDUFA establishment or product fees for FY 2014:
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.
User Fees and Forms
This site provides information on various user fee-related issues. If you have questions about user fees, you can contact the Prescription Drug User Fee Staff at 301-796-7900. 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 2014 (PDF - 210KB) (posted 8/1/2013)
- PDUFA User Fee Cover Sheet
PDUFA V Information Technology/Informatics Plan FY 2013 – FY 2017(PDF - 447KB) U.S. Food and Drug Administration Statement: The impact of Hurricane Sandy on Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) deadlines User Fees: Ensuring a Stronger and Better FDA PDUFA User Fee Cover Sheet Frequently Asked Questions on Prescription Drug User Fees (PDUFA)