Prescription Drug User Fee Act (PDUFA)

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
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2010 (PDF - 61.6 KB) (Posted 8/3/2009)
The Dear Colleague Letter, in anticipation of FY 2010 Invoices, was mailed Tuesday, May 5, 2009. If you do not receive the letter by May 19, 2009, please contact Michael 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 - 61.6 KB) (Posted 8/3/2009)
User Fee Rates Archive
PDUFA User Fee Cover Sheet
Payment Instructions for Applications and Supplements

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Prescription Drug User Fee Act (PDUFA)