Drug Kennel http://www.camargoblog.com Drug Development Comments - Focused on 505(b)(2) Mon, 09 Jan 2012 16:14:11 +0000 http://backend.userland.com/rss092 en 2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals http://www.camargoblog.com/index.php/2012/01/09/2011-505b2-approvals-now-exceed-505b1-nda-approvals/ What is an Approved DESI Product? http://www.camargoblog.com/index.php/2011/12/21/what-is-an-approved-desi-product/ Stability Changes coming to ANDAs http://www.camargoblog.com/index.php/2011/10/04/stability-changes-coming-to-andas/ Don’t launch unapproved products after 9/19/2011 http://www.camargoblog.com/index.php/2011/10/03/dont-launch-unapproved-products-after-9192011/ AB Rated 505(b)(2)’s http://www.camargoblog.com/index.php/2011/09/11/ab-rated-505b2%e2%80%99s/ 2012 PDUFA User Fees http://www.camargoblog.com/index.php/2011/08/07/2012-pdufa-user-fees/ Whew! Supreme Court rules generic labels must track RLD http://www.camargoblog.com/index.php/2011/06/24/whew-supreme-court-rules-generic-labels-must-track-rld/ KV’s Makena Part 4: Statistical versus Clinical Significance http://www.camargoblog.com/index.php/2011/06/14/kvs-makena-part-4-statistical-versus-clinical-significance/ Patent Cliff Causes Pfizer Cuts http://www.camargoblog.com/index.php/2011/06/09/patent-cliff-causes-pfizer-cuts/ Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products http://www.camargoblog.com/index.php/2011/06/08/role-of-in-vitro-in-vivo-metabolism-studies-in-505b2-drug-development-of-metabolite-products/