3 months to get the labelled changed, organise and facilitate a human factors trial to demonstrate people can follow the instructions accurately, and then resubmit the application. THEN, the FDA have UP TO 6 months to provide their decision. It could come earlier, but as the FDA expert said on the Webinar, most likely the FDA will take the full 6 months to provide their decision. That's FDA bureaucracy for you, but it is what it it.
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