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Generic User Fee Hikes Could Disrupt US FDA Drug Pricing Campaign

 
• By Derrick Gingery

New GDUFA program fee is high enough that sponsors may withdraw applications to reduce their fee exposure, agency estimates.

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New user fees could reverse efforts by the US FDA to increase generic drug availability and push drug prices down.

The agency announced the generic drug user fees for fiscal year 2018, the first year of GDUFA II, in a Federal Register notice scheduled to be published Aug....

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US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.