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PDUFA Application Fee Nears $3m Threshold In FY 2020

 
• By Derrick Gingery

The US FDA fee for a new drug or biologics license application requiring clinical data will jump to $2.94m in October.

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Workload volume continues to push PDUFA application fees higher. • Source: File photo

A continued increase in workload coupled with a drop in fee-paying applications helped push prescription drug user fees higher in fiscal year 2020.

The headline number – the cost to file an application requiring clinical data – is approaching the $3m mark. Sponsors...

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