FDA Prescription Drug User Fee Rates: Fiscal Year 2017

August 2, 2016

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.

Are you developing an FDA-regulated product? We can help you get your product approved by the FDA in less time and for less money. To learn more about our unique approach that combines scientific knowledge with regulatory expertise and how that has helped our clients achieve a successful outcome with FDA, contact us today.



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