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Everything's Special At US FDA: Priority NDA/BLA Filings Surge

 
• By Derrick Gingery

The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.

FDA entrance sign 2016
The FY 2018 PDUFA Performance Report also detailed falling median approval times. • Source: File photo

Standard assessment periods may be losing favor with sponsors of new drugs and biologics, creating more stress for the US Food and Drug Administration staff.

Priority application filings, which promise an eight-month review rather than the standard 12-month review, showed a dramatic increase in fiscal...

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