'Program Alignment': 10 Things You Always Wanted To Know About FDA's New Inspection Scheme (But Were Afraid To Ask)
Executive Summary
Now that US FDA's "program alignment" inspection paradigm is in full swing, does your device firm know where to send an FDA-483 response? How to alert the agency about a recall? Who to contact if there is a problem with an FDA investigator? If not, then check out the answers to those questions – and seven more – in this feature article.
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