CDER electronic review pilot study is under way, starting with bioequivalence data -- Woodcock at DIA.
Executive Summary
CDER ELECTRONIC REVIEW PILOT STUDY UNDER WAY for automated analysis of certain portions of drug 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 annual Drug Information Association meeting in Montreal June 24. "This pilot is going very well," Woodcock said, but cautioned 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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