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Cold Indication For Antihistamine Monograph Expected This Year – DNDP Director Michele

This article was originally published in The Tan Sheet

Executive Summary

FDA this year will publish an antihistamine monograph rule stemming from a partnership with Canada, says Theresa Michele, director of the Division of Nonprescription Drug Products. At a recent CHPA conference, Michele suggested FDA will parlay strong momentum and internal improvements from 2015 into 2016 progress.


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