CHPA Plans Pharmacokinetic Trials On Pediatric OTC Cough/Cold Drugs
This article was originally published in The Tan Sheet
Executive Summary
Companies are in discussions with FDA about conducting pharmacokinetic studies to confirm or refine pediatric cough/cold ingredient dosing in children age 2 to 12, according to the Consumer Healthcare Products Association
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House appropriators want FDA to propose by Dec. 31 revised labeling for OTC pediatric cough and cold products that addresses safety and efficacy concerns.
House Appropriators Push For Revised Pediatric Cough/Cold Labels
House appropriators want FDA to propose by Dec. 31 revised labeling for OTC pediatric cough and cold products that addresses safety and efficacy concerns.