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

 
• By Malcolm Spicer

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.

House appropriators want FDA by the end of June to issue a proposed rule revising the monograph regulating the labeling of OTC cough and cold products for children.

According to their report published with House legislation that includes FDA’s fiscal 2015 funding, appropriators recommend the agency by June 30, 2014, publish a proposed rule based on scientific evidence...

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