Compounding User Fees Reinforce Inspections As Central To FDA

 

By Sarah Karlin / Email the Author / View Full Issue
Regulatory Update / Word Count: 1568 / Article # 00140414010 / Posted: May 5 2014 12:01 AM

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Executive Summary

Guidance serves as reminder that inspections are at heart of FDA mission, particularly when it comes to quality enforcement; fees are bargain compared to GDUFA, PDUFA, but come with penalties for reinspection.

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