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  1. FDA User Fee Programs

Prescription Drug User Fee Amendments

Latest News:

  • In preparation for FDA’s FY 2023 PDUFA program fee invoices, the Dear Colleague Letter (DCL) was emailed on Monday, May 2, 2022 for PDUFA user fee eligible products. Please submit your response to CDERCollections@fda.hhs.gov by Wednesday, June 1, 2022. If you have any questions regarding the DCL, please send an email to the Dear Colleague Letter Coordinator at CDERCollections@fda.hhs.gov.
  • 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.
  • 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.

FY 2022 and FY 2023 User Fee Rates:

User Fee Type 2022 2023
Application Fee – Clinical Data Required $3,117,218 $3,242,026
Application Fee – No Clinical Data Required $1,558,609 $1,621,013
Program Fee $369,413 $393,933

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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