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Meanwhile, what's up with the development of Palladone?
And why is it taking so long? Canada, the UK, France, Belgium, Holland, Germany and probably more countries have had both the IR and ER versions for many many years.
I already know that the FDA relies on kickbacks to approve new drugs in the USA, but then again, we've had Dilaudid here for a while?
The compound is tried and tested, so why should the formulation be such a stumbling block?
I know they seem impossible to please, and their rules are tight, and many a drug in development has been sent back to the drawing board. Got to be frustrating for the poorer pharmaceutical companies that have already sunk, oh, $30 million into r&d. I'd say it can make or break some companies, and allow the FDA to pick and choose whom they want to survive. Don't like company Y because, say, they're French? (imagine dun! dun! DUN! scary film score-like music). Well, let's pick on a few faults here, a form not filled out correctly there, and send them back while Pfizer or Eli Lilly make off with the grand prize. Not that most Euro companies don't know exactly how to play the game, though...
Am I seeing this incorrectly? I probably am, but would like to know how and why. Anybody have any insight into the inner workings of the FDA? I am particulary interested in how it is that they can influence drug policy abroad, such as in the case of Survector and Reboxetine.