I agree the FDA can issue an extension for almost any reason. But there appeared to be more than normal the amount of extensions for the first half of this year, coinciding with preparation for and the congressional hearing about PDUFA V. It is my believe that the effort the FDA put forth in obtaining approval of that legistration is primary cause for the extension. Or as indicated by others a political ploy to increase funding and fees (which it did).
As far as labeling, other PDUFA have been approved while labeling requirements were still under negotiation.
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