Compliance Management / Generic / Large Molecule / Small Molecule

FDA Announces User Fee Increases Effective October '15

Aug 05, 2015

Regulatory Affairs Professionals Society

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2016, as reported in the Regulatory Affairs Professionals Society (RAPS). The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFAV), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products.

See the chart with FY2016 rates in the RAPS article