Federal Register Notice: FDA will hold a public hearing 10/2 to obtain input on over-the-counter cough and cold drugs marketed for pediatric use. Recently, safety and efficacy concerns have been raised on the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. The agency is developing a proposed rule to revise the pediatric labeling contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. At the hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rulemaking and reviews NDAs for these ingredients. The hearing will take place from 8 a.m. to 5 p.m. at the Sheraton Washington North Hotel, 4095 Powder Mill Rd., Beltsville, MD. Contact Faith Dugan, (301) 796-3446. To view this notice, click here.