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Shutdown Week Three: Sponsors With Upcoming User Fee Dates Should Start Sweating

 
• By Derrick Gingery

US FDA has enough carryover funding for another month of operations, Commissioner Gottlieb says, potentially endangering late February and March review goals.

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As the partial shutdown of the US FDA enters its third week, sponsors with user fee goals in late February and beyond may be feeling a little more anxious and hoping for a resolution of the stand off between President Trump and Congressional Democrats over funding of a boarder wall.

The agency has been able to maintain many review functions during the shutdown with existing user fee dollars, but Commissioner...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
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US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
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EU Tests Unified Pathway For Combined Drug/IVD Studies

 
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