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Elite Pharmaceuticals Inc ELTP
Posted On: 08/23/2013 10:41:29 AM
Post# of 2146
Posted By: mrwrn2010
Wow is this for real?

http://www.camargopharma.com/case-studies.asp...pplication


NDA Fast-Track Application


Camargo expedites approval of NDA application

















Challenge Disarm skepticism among sponsor's senior management that any faster regulatory path than a traditional NDA submission would be accepted by the FDA
Details When the FDA rejected a sponsor's application for orphan drug status for a key drug in its pipeline, the sponsor approached Camargo for alternate strategies to expedite approval. Camargo's team of regulatory experts recommended the FDA fast track application approach. The team educated the sponsor about the FDA fast track drug development program, and advised the sponsor of the appropriate data to include in the application. The sponsor promptly provided the data to Team Camargo. Within four weeks, Camargo's regulatory, research and medical writing team had submitted an application to the FDA. It included the data necessary to make the case for fast track review of the sponsored drug. Within six weeks of submission to the FDA, the agency approved the fast track application.
Value Thanks to the efforts of Team Camargo, the sponsor's drug achieved high priority within the FDA, thus accelerating review and time to approval.


Fast tracking the product got it approved within like.. less than 3 months? Thats insane.













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