FDA Prescription Drug User Fee Rates: Fiscal Year 2016

August 7, 2015

As amended by the Prescription Drug User Fee Amendments of 2012, The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect fees from sponsors submitting applications for the review of human drug and biological products, the manufacturing facilities, and on the products themselves. In order to account for inflation and meet the needs of the Agency, these rates are adjusted on an annual basis and are effective each fiscal year from October 1 to September 30.

The rates for fiscal year 2016 were recently announced by the FDA, and are as follows:

Fee Category

Fee Rates for FY 2016

Applications:  
Requiring Clinical Data

$2,374,200

Not Requiring Clinical Data

$1,187,100

Supplements Requiring Clinical Data

$1,187,100

Establishments

$585,200

Products

$114,450

 

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