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Designation as a fast track product enables Pharmaxis to file the new drug application on a rolling basis as data becomes available, allowing the FDA to review the application in sections ahead of receiving the complete submission. Treating low acuity patients in a separate fast track area within hospital emergency departments can ease the pressure on Australian public hospitals according to a recent study. But--since Congress extended fast track negotiating authority (now called Trade Promotion Authority) in 2002--the United States has concluded nine Free Trade Agreements. |
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