Friday, October 28, 2011 11:40:37 PM
I can't help to think of what the FDA is thinking right now because on numerous occasions Margaret Hamburg herself pointed to the M-Enox approval as being the model for her soon to be released bio-generic approval process. I certainly wouldn't think her idea is to just create numerous duopolies for each drug which again would be saddled by a patent term. The ink's not dry on any paperwork, either from the FDA or HHS, and I'm pretty sure it'll be looked at.
In the meantime, let's enjoy.
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