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Pediatric Acetaminophen Expanded Dosing Requested In McNeil Petition

This article was originally published in The Tan Sheet

Executive Summary

Expanded dosing directions in the labeling of pediatric acetaminophen products to include children under two is requested by McNeil Consumer Healthcare in a citizen petition filed with FDA Feb. 1.

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CHPA Agenda 2014: Monograph Reform, NSURE Progress

The Consumer Healthcare Products Association plans to tackle big tasks in 2014, including working with FDA to improve the monograph system, move the new Rx-to-OTC switch paradigm forward and determine quality metrics to help FDA better target inspections. The trade group also is looking for ways to ease pricing pressures and ensure quality does not suffer.

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