FDA Prescription Drug User Fee Rates: Fiscal Year 2017

The Prescription Drug User Fee Amendments of 2012 (PDUFA V) allows FDA to collect user fees for the review of applications concerning human drug and biological products, the establishments where these products are made, and on the products themselves.  Each year these rates are adjusted in order to meet the needs of the Agency and to account for inflation.  As such, last week the FDA released its rates for fiscal year 2017, which are as follows:

Fee Category:

FY 20147 Rates:

Application Requiring Clinical Data

$2,038,100

Application not Requiring Clinical Data

$1,019,050

Establishment

$512,200

Product

$97,750

 

FDA has decreased these fees, as compared to its 2016 rates.  The new rates take effect on October 1, 2016, and will remain constant until September 30, 2017, when the FDA’s FY 2018 rates will take effect.

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