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Monograph System Challenges Underscored By Pediatric Cold Debate

This article was originally published in The Tan Sheet

Executive Summary

Concerns about the safety and efficacy of nonprescription pediatric cough/cold products point to the need to re-examine the monograph system in the future, according to University of Florida pharmacy and pediatrics professor Leslie Hendeles, Pharm.D

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Patient Symptoms Are Better Measure Of Decongestant’s Efficacy – FDA

The patient self-assessed nasal congestion symptom score, not nasal air resistance, is the preferred tool to evaluate the effectiveness of an oral nasal decongestant such as phenylephrine, according to a report by a division of FDA's Office of New Drugs

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