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THIRD PARTY REVIEW OF PREMARKET APPLICATIONS TO IMPROVE REVIEW TIMES

This article was originally published in The Gray Sheet

Executive Summary

THIRD PARTY REVIEW OF PREMARKET APPLICATIONS TO IMPROVE REVIEW TIMES likely will be a focus for Republicans in the 104th Congress looking to increase efficiency in FDA's device, biologics, and drug premarket review programs. Under such a system, independent organizations outside FDA would be responsible for reviewing some or all the information in submissions such as premarket approval applications and 510(k)s.
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