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Panels to Discuss Children’s Cold Products

08/16/2007

Federal Register Notice: FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee will meet 10/18-19, from 8 a.m. to 5 p.m. at the National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Ave., Silver Spring, MD. Contact Darrell Lyons, (301) 827-7001. The committees will discuss the safety and efficacy of OTC cough and cold products marketed for pediatric use. A 3/1 citizen petition raised concerns about the safety and efficacy of cough and cold products in children under 6 years of age and asked that the agency amend the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products in 21 CFR Part 341 to require that labeling for OTC antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products state that these products have not been found to be safe or effective in children under 6 years of age for treating cough and cold, and that these products should not be used for these patients. To view this notice, click here.

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