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FDA takes more time for cough/cold amendment

This article was originally published in The Tan Sheet

Executive Summary

FDA pushes back the targets dates for a proposed amendment to the cough/cold monograph from June to December 2010 and a final OTC monograph rule from May to October 2010, according to the Department of Health and Human Services' semi-annual regulatory 1agenda published April 26. FDA said in August 2008 it would propose revised labeling under the current final cough/cold monograph in response to concerns about pediatric cough and cold products (2"The Tan Sheet" Aug. 25, 2008). FDA's final monograph for sunscreens emerged in 1999, but industry pressure consistently has stayed its publication

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