CDER electronic review pilot study under way, CDER's Woodcock tells DIA.
This article was originally published in The Tan Sheet
Executive Summary
CDER ELECTRONIC REVIEW PILOT STUDY UNDER WAY for automated analysis of certain portions of drug approval applications. "We are looking at ways to do computer-assisted review of data sets using standardized tools," FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, reported at the recent Drug Information Association annual meeting in Montreal. "This pilot is going very well," Woodcock said cautioning that "we need to go a long way on standardizing the data that is submitted before we can actually use it."
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