FDA kicks off GDUFA III reauthorization process
In a public meeting held via webcast, officials of the FDA kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency’s third GDUFA program.
GDUFA II, authorized in 2017, expires at the end of September 2022. The GDUFA II agreement had two major objectives in speeding access to generic drugs, said Maryll Toufanian, director of the Office of Generic Drug Policy at CDER’s Office of Generic Drugs (OGD) at the meeting. The first was to reduce the number of review cycles to approval, and the second was to increase the number of generic drugs approved while maintaining safety and quality standards.
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