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Generic Drug User Fee Projections Complicated By Shifting Personnel Costs

 
• By Derrick Gingery

After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.

inflation and deflation graph
The FDA and industry are discussing potential changes to GDUFA user fee calculations as part of renewal negotiations. • Source: Shutterstock

Changing personnel costs at the US Food and Drug Administration may be creating anxiety about the stability of generic drug user fee program funding.

As part of its proposals “intended to set a sound foundation for continued programmatic success” that could help “facilitate earlier approvals,” FDA officials and generic drug industry representatives discussed “how inflation adjustments may need to be tailored to the program,” according to

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