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US FDA May Start To Miss User Fee Deadlines

 
• By Nielsen Hobbs

As the COVID-19 response begins to strain agency’s resources, Commissioner Hahn acknowledges that ‘it is possible that we will not be able to sustain our current level of performance indefinitely’ in other review areas.

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The US FDA's product review engine is still running despite the strain of COVID-19, but it's starting to overheat.

US FDA Commissioner Stephen Hahn acknowledged in a 16 April statement that the strain the agency is feeling from its coronavirus response could cause it to miss some of its user fee deadlines.

“At this time, the New Drug Program, the Generic Drug Program, and the Biologics and Biosimilars Programs are continuing to meet key review program user fee performance goals, approve applications...

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