The U.S. Food and Drug Administration (FDA) announced a public hearing on October 2 to obtain input related to over-the-counter (OTC) cough and cold drugs marketed for pediatric use. The public hearing will be held from 8:00 a.m. to 5:00 p.m. at the Sheraton Washington North Hotel in
Beltsville, Md.
The agency said many nonprescription cough and cold drug products are marketed under the OTC Drug Review, which established a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. Recently, safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. FDA said it 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 public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory and product-use issues as it proceeds with the rulemaking and reviews new drug applications for these ingredients. For more information, visit www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0466-nhc.pdf
