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NDA User Fees Will Climb Almost 16% On Oct. 1

Executive Summary

US FDA completes updates for biosimilars and novel drug fee schedules as PDUFA VI is set to begin.

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PDUFA Application Fee Nears $3m Threshold In FY 2020

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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Fees for applications and approved products will stay the same, while product development levies will fall 36%, the FDA announces. The agency’s biosimilar activities are becoming more reliant on funding from the growing number of products approved and less on those still in development.

US Orphan Fee Waiver Requests Must Include Much More Extensive Documentation

In update of 2011 draft guidance, FDA gives more detail on documentation needed for orphan sponsors to receive a program fee waiver; Guidance also suggests the agency is no longer working with SBA to make small business determinations.

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