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

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