Translating science to approval: The GDUFA science and research program

In September 2022, the US President re-authorized the Generic Drug User Fee Amendments (GDUFA). This new iteration is known as GDUFA III and takes effect from October 2022 to September 2027.1

Originally signed in 2012, the GDUFA was created to improve both accuracy and efficiency in drug development, while providing innovative methodologies and improving communication between industry, regulators, and the public. All generic drug manufacturers, including those manufacturing active ingredients only, are required to submit tiered user fee(s) to the US Food and Drug Administration (FDA) that will in turn support critical program functions, research, regulatory assessment and education via public workshops, online education, and other modalities.

In the fiscal year 2023, fee revenue amount for GDUFA III is $582,500,000.2 One of the uses of this revenue is to fund the science and research program for generic drugs, which provides critical insights to enable drug manufacturers to move their products faster from drug development to obtaining regulatory approval.3