http://pharmaweblog.com/blog/2005/09/07/emdac-to-consider-inhaled-insulin-tomorrow-briefing-materials/ Pharmaceutical and biotech science and business Fri, 29 Aug 2008 23:28:21 +0000 http://wordpress.org/?v=2.0.2 http://pharmaweblog.com/blog/2005/09/07/emdac-to-consider-inhaled-insulin-tomorrow-briefing-materials/#comment-95 Fri, 19 Oct 2007 17:14:14 +0000 http://pharmaweblog.com/blog/2005/09/07/emdac-to-consider-inhaled-insulin-tomorrow-briefing-materials/#comment-95 [...] Prior to the review by FDA’s EMDAC in September 2005, I discussed some of the briefing information regarding pulmonary safety: One has to wonder how Pfizer plans to manage the liability risk of Exubera. They’ve appropriately proposed a raft of post-marketing studies designed to better quantify the clinical risks of the drug in a variety of patients, but at the same time they have suggested that Exubera is safe to use in patients with mild to moderate asthma or COPD, in contrast to the internal FDA pulmonary consultant’s review, which indicated that current data were insufficient to draw such a conclusion. This leads me to believe that Pfizer is planning to fight to avoid a contraindication to use in such patients, clearly an anti-conservative position. [...] […] Prior to the review by FDA’s EMDAC in September 2005, I discussed some of the briefing information regarding pulmonary safety: One has to wonder how Pfizer plans to manage the liability risk of Exubera. They’ve appropriately proposed a raft of post-marketing studies designed to better quantify the clinical risks of the drug in a variety of patients, but at the same time they have suggested that Exubera is safe to use in patients with mild to moderate asthma or COPD, in contrast to the internal FDA pulmonary consultant’s review, which indicated that current data were insufficient to draw such a conclusion. This leads me to believe that Pfizer is planning to fight to avoid a contraindication to use in such patients, clearly an anti-conservative position. […]

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