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FDA Emphasizes Timesavers In New eCopy Guidance

This article was originally published in The Gray Sheet

Executive Summary

CDRH has again updated its eCopy guidance to highlight tools that the device center believes will speed up the premarket submissions and review process. The new document clarifies how the center wants sponsors to submit PDF files, spotlights a submission validation tool and includes other tips to reduce unnecessary eCopy holds that can delay submissions, a center official tells "The Gray Sheet."


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