I would have thought that if someone is applying to the FDA then they would know certain requirements, etc.
Same goes for the RCH application, surely there were conversations and guidelines were given before the application was made.
Over my years Ive applied for and been granted Australian Standards approval (which i know is different but its still doing detailed applications) on a number of different products.
One needs to communicate and do their homework so that the application is a success.
More disappointment, why am i not surprised.!!!!!
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