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Breakthrough Therapy Designations Set Quarterly Record

 
• By Michael Cipriano

US FDA granted designations for several products based on late-stage data; with at least 19 breakthrough therapy designations, five-year-old program sets another record in first quarter of 2018.

FDA entrance sign 2016

Breakthrough therapy designations continue to set records at the US FDA – this time another quarterly one.

Publicly announced receipts of the expedited pathway totaled 19 in the first quarter of 2018, according to data from Biomedtracker...

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Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
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With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
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More from Pathways & Standards

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Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
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