Wow is this for real? http://www.camargopharma.co
Post# of 2146
Posted On: 08/23/2013 10:41:29 AM
Wow is this for real?
http://www.camargopharma.com/case-studies.asp...pplication
Fast tracking the product got it approved within like.. less than 3 months? Thats insane.
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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