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Trimming The Tree: What’s In The PDUFA Legislative Package – And What’s Out

 
• By Nielsen Hobbs

The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.

FDA ornament
It's beginning to look a lot like the user fee legislation will pass the House without drama. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

Because it is considered “must pass” to keep the agency operating, the FDA user fee renewal attracts a large number of bills hoping to be included, and the resulting legislation is often referred to as “Christmas Tree” in Capitol Hill parlance.

The draft House bill unveiled by Democratic and Republican committee leadership on 4 May is no exception. Below is a graphic of some of the major provisions, based on a

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
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The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

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US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
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UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
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