Posts Tagged priority

Columbia Laboratories files Prochieve NDA with FDA …

Wednesday, April 27th, 2011 | Permalink

“We now await notice from the FDA on whether our NDA submission has been accepted for filing, as well as a decision on our request for Priority Review which, if granted, could result in an action letter from the FDA in the fourth quarter of this year,” … SHL Group – Designer, Developer & Supplier of Auto Injectors & Pen Injectors SHL (Scandinavian Health Ltd.) is the world's largest privately-owned designer, developer and supplier of advanced drug delivery devices .

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Columbia Laboratories files Prochieve NDA with FDA …