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UPDATED: 10 Things You Need To Know About FDA's 'Program Alignment' Inspectional Reorg

 
• By Shawn M. Schmitt

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 updated feature article.

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[Editor's note:A version of this story was originally posted on Feb. 20, 2018. It has been updated to reflect staffing changes for "program alignment."]

As US FDA celebrates the first anniversary of its "program alignment" inspection scheme, the agency says the massive reorganization is...

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More from Policy & Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
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