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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...

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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
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Generic Drug Office’s Policy Staff Returning To US FDA

 
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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

House Gives US FDA More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

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