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Priority Reviews At US FDA: From Third Quarter Spikes To A Third Quarter Trough

 
• By Michael Cipriano

Priority review announcements saw significant dip in third quarter 2018, while they usually experience a spike during the period; breakthrough therapy designations remained in double digits.

group of businessman in black suit and holding red arrow down graph

Priority review designation announcements regarding applications pending at the US FDA have generally spiked in the third quarter over the last several years, with 2016 being the exception. But not only have they failed to peak in third quarter of 2018; it looks like the three-month stretch will prove to be a notable trough.

After achieving respective totals of at least 21 and 28 in the first and second quarters of this year, sponsors announced only 12 priority review designations in the third quarter...

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