Posts Tagged fda

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 …

FDA to lift Allergy Therapeutics INDs clinical hold – Pharmaceutical …

Tuesday, April 26th, 2011 | Permalink

The FDA has asked the company to submit its study protocols to the INDs for further discussions in order to provide review and feedback on the proposed studies. Allergy Therapeutics CEO Manuel Llobet said they are …

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FDA to lift Allergy Therapeutics INDs clinical hold – Pharmaceutical …