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  1. FDA User Fee Programs

Prescription Drug User Fee Amendments

Latest News:

  • CDER’s Work to Meet User Fee Goals During the Pandemic: This webpage will provide periodic updates on key user fee metrics related to application review and the pre-approval process throughout the COVID-19 pandemic.
  • The FY 2021 Clean-Up Program Fee invoices were emailed on Monday, December 14, 2020.  Full payment of the clean-up invoice is due on January 14, 2021.  If you do not receive your invoice by Thursday, December 17, 2020, but believe you should have, please contact the PDUFA User Fee staff at CDERCollections@fda.hhs.gov
  • IMPORTANT NOTICE REGARDING PRESCRIPTION DRUG USER FEE STAFF CONTACT INFORMATION: Due to the COVID-19 pandemic, and until further notice, electronic mail is the Prescription Drug User Fee staff’s preferred method of receiving communication over postal mail.  If you have questions or documentation for the Prescription Drug User Fee staff regarding PDUFA Fee requirements, waivers, reductions or refunds, please send them by electronic mail to CDERCollections@fda.hhs.gov.  Please continue to contact the User Fee Helpdesk at userfees@fda.gov for questions about making or confirming the status of a payment.
  • The FY 2021 PDUFA fee rates were published in the Federal Register (FR) on August 3, 2020. For more information regarding the FY 2021 fee rates, please see the FR notice available at: https://www.federalregister.gov/documents/2020/08/03/2020-16833/prescription-drug-user-fee-rates-for-fiscal-year-2021

FY 2020 and FY 2021 User Fee Rates:

User Fee Type 2020 2021
Application Fee – Clinical Data Required $2,942,965 $2,875,842
Application Fee – No Clinical Data Required $1,471,483 $1,437,921
Program Fee $325,424 $336,432

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and 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.

PDUFA must be reauthorized every five years, and was renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V) and 2017 (PDUFA VI). On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of PDUFA through September 2022. PDUFA VI will provide for the continued timely review of new drug and biologic license applications.

 



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