Published in Medical Letter on the CDC and FDA, August 7th, 2005
The FDA indicated it would review EPIX's new drug application (NDA), including the May, 2005, submission, with a target date for an action letter in late November 2005. The FDA also encouraged EPIX to consider a reread of the images from the phase III trials to provide additional information about the usefulness of dynamic versus steady state images, and to schedule a meeting with the FDA to...
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