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COMPARATIVE CLAIMS DATA WILL NEED TO BE "MORE RIGOROUS" RATHER THAN LESS -- CDER DIRECTOR WOODCOCK; POSITION ON COMPARATIVE ADS PRELIMINARY BUT ADVANCING

Executive Summary

Comparative claims and cost-effectiveness claims may need to be based on data that is more rigorous than industry may presume, and not less rigorous than expected of a regular NDA submissions, Center for Drug Evaluation & Research Director Janet Woodcock suggested at a briefing for trade journalists June 28.
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