http://www.pharmalot.com/2008/09/fda-delays-approval-for-roche-arthritis-drug/ News, Comment and Conversation Fri, 10 Feb 2012 22:18:00 +0000 http://wordpress.org/?v=2.6.2 http://www.pharmalot.com/2008/09/fda-delays-approval-for-roche-arthritis-drug/#comment-374303 Fred Clay Fri, 19 Sep 2008 09:52:00 +0000 http://www.pharmalot.com/?p=15717#comment-374303 I'd say let the FDA satisfy itself, completely. Examples of drug recalls are aplenty, including that of the infamous drug "Vioxx." Good to learn that FDA's concern's are not about safety in this case, it's manufacturing and documents. But those are important too. Remember that only recently the FDA in an import alert stated, that it may detain APIs from the Indian drugmaker Ranbaxy due to quality issues. For Roche - "He that can have Patience, can have what he will” Benjamin Franklin - in this case, a "billion-dollars." I’d say let the FDA satisfy itself, completely. Examples of drug recalls are aplenty, including that of the infamous drug “Vioxx.” Good to learn that FDA’s concern’s are not about safety in this case, it’s manufacturing and documents. But those are important too. Remember that only recently the FDA in an import alert stated, that it may detain APIs from the Indian drugmaker Ranbaxy due to quality issues. For Roche - “He that can have Patience, can have what he will” Benjamin Franklin - in this case, a “billion-dollars.”

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