FDA Prescription Drug User Fee Rates: Fiscal Year 2016

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

Requiring Clinical Data


Not Requiring Clinical Data


Supplements Requiring Clinical Data







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!