Question

"The FDA Safety and Innovation Act of 2012 gave FDA the authority to collect user fees from industry to fund and speed up reviews of different types of drugs. In the Generic and Biosimilars UFA, the final user fees are what percent of the typical user fees for a branded drug PDUFA?"

-30%
-50%
-90%
-10%
-20%

Answer 1

The Generic and Biosimilars User Fee Amendments fees for a generic drug are 20% of the typical user fees for a branded drug under the Prescription Drug User Fee Act.

Step-by-step explanation:

The FDA Safety and Innovation Act of 2012 allowed the Food and Drug Administration (FDA) to collect user fees from the industry for the purpose of funding and expediting drug reviews. This includes generic drugs as well as biosimilars.

When comparing the final user fees collected for the Generic and Biosimilars User Fee Amendments (GDUFA) to the Prescription Drug User Fee Act (PDUFA) fees for branded drugs, the fees for GDUFA are set at a certain percentage of typical branded drug fees. For a generic drug, the fees are 20% of the PDUFA fees for branded drugs.