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House Appropriators Watch Clock On OTC Cough/Cold, Sunscreen Monographs

This article was originally published in The Tan Sheet

Executive Summary

House appropriators recommend FDA in June publish a proposed rule for safety and efficacy of cough/cold OTCs in pediatric populations They also direct FDA by December to complete its review of the remaining sunscreen ingredient safety and effectiveness TEA submissions.

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Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda

Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.

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.

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