FDA Draft Raises Ruckus, Allows Drugmakers To Distribute Off-Label Info In Clinical Journals
This article was originally published in The Pink Sheet Daily
Guidance would fill a regulatory gap caused by September 2006 sunset of FDAMA, agency says.
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The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter
Despite receiving a “complete response” letter and manufacturing warning letter on the same day, Genzyme remains upbeat about the likelihood of approval for its 2,000L scale-up of Myozyme.
In an era where most product- and innovation-hungry big pharma firms have been desperately promoting themselves as "best partners," it is perhaps easy to forget what can go wrong when a biotech entrusts its asset to a larger firm