Breakthrough, Priority Review Designations Could Set High-Water Marks In 2018

Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018. 

While the Center for Drug Evaluation and Research (CDER) is likely to set a novel drug approval record in 2018, that likely won't be the only high-water mark the US FDA reaches this year, as the agency is well-positioned to set records for breakthrough therapy and priority review designations as well.

Through the first half of 2018, sponsors have publicly announced the receipt of at least 31 breakthrough therapy designations, according...

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