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akasidney86

06/09/07 4:16 PM

#4195 RE: maharajah #4190

BTW, I do not know of any occurrence of a company successfully not responding to a 483

More to the point, can a company pursue a successful BLA outcome with a 483 pending? Seems to the unwashed that the answer to that would be a resounding no.
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io_io

06/09/07 6:13 PM

#4215 RE: maharajah #4190

<<<<<"observations of non-compliance with cGMPs">>>>

A long way from the green-mail statement by the ambulance chasers of "violation of FDA regulations".