For Industry

Prescription Drug User Fee Act (PDUFA)

Notice to applicants who owe PDUFA establishment or product fees for FY 2014:

In accordance with PDUFA, 21 U.S.C. § 379h(a)(2)(A) and (a)(3)(A), prescription drug establishment and product fees for FY 2014 are due “on...the first business day after the enactment of an appropriations Act providing for the collection and obligation of  [PDUFA] fees for fiscal year [2014].”  Because the Continuing Resolution (an appropriations Act) for fiscal year 2014 was enacted on October 17, 2013, prescription drug establishment and product fees assessed for fiscal year 2014 are due on October 18, 2013.

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.


News 
  • FY 2015 product and establishment fee invoices were mailed on Friday, August 15, 2014. These invoices are due by October 1, 2014. If you do not receive a copy by September 1, 2014, please contact Katie Stronati or Beverly Friedman at 301-796-7900.

  • The FY 2015 user fee rates have been published: Establishment of Prescription Drug User Fee Rates for Fiscal Year 2015 (posted 8/4/2014)

  • Effective immediately, FDA’s PDUFA User Fee Staff has a new phone number: 301-796-7900. Please use this number for all PDUFA User Fee inquiries. (posted 8/16/2013)

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.

 

Page Last Updated: 10/09/2014
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