http://blog.pharmexec.com/2008/07/11/fda-to-pharma-no-more-drug-rejections/ The Business of Pharmaceuticals Thu, 02 Sep 2010 10:36:09 -0400 hourly 1 http://blog.pharmexec.com/2008/07/11/fda-to-pharma-no-more-drug-rejections/comment-page-1/#comment-4588 No More Approvable Letters: An Expert’s Take Wed, 16 Jul 2008 18:34:03 +0000 http://blog.pharmexec.com/2008/07/11/fda-to-pharma-no-more-drug-rejections/#comment-4588 [...] response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and [...] [...] response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and [...]

]]> http://blog.pharmexec.com/2008/07/11/fda-to-pharma-no-more-drug-rejections/comment-page-1/#comment-4584 Sally Staude Wed, 16 Jul 2008 13:35:50 +0000 http://blog.pharmexec.com/2008/07/11/fda-to-pharma-no-more-drug-rejections/#comment-4584 But what does this do abobut the FDA giving specific guidance about whic studies to do, then a company does them, then they come back to FDA and are told they didn't do the right studies???? But what does this do abobut the FDA giving specific guidance about whic studies to do, then a company does them, then they come back to FDA and are told they didn’t do the right studies????

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