2018年 PDUFA Fees and Program Invoice Update

Dear Colleague,

• The PDUFA User Fee staff is currently finalizing the annual FY 2018 Program Fee invoices.  We anticipate that invoices will be emailed by the last week of September 2017.  If you do not receive your invoice by September 28, 2017, please contact PDUFA User Fee staff at [e-mail]. 
  

• The FY 2018 PDUFA fee rates were published in the Federal Register (FR) on September 14, 2017. The fee rates for FY 2018 are shown below: 

PUFA User Fee Rate Types	FY 2018
Application Fee – Clinical Data Required	$2,421,495
Application Fee – No Clinical Data Required	$1,210,748
Program Fee	$304,162

• For more information regarding the FY 2018 fee rates, please see the FR notice available at:

         http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm152775.htm

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