To help ensure FDA continues to have sufficient resources to carry out its mission, Congress enacted the first Generic Drug User Fee Amendments (GDUFA) in 2012. GDUFA specifies various fees the agency sets and can collect from manufacturers, such as ANDA applications, Drug Master Files(DMF) and facility and program fees. In turn, the fees aid FDA’s ability to meet agreed-upon performance goals or commitments, such as timeline reviews and other regulatory activities. FDA also committed to providing annual reports to Congress on its performance. The increases in transparency and communication are important to FDA’s ability to meet the commitments, which enhances the overall stability and predictability of the GDUFA program.
To learn more, download the fact sheet.