Unique role of consumer studies in nonprescription drug development.

OBJECTIVE: To inform the health care community about nonprescription drug labeling and consumer studies unique and integral to the nonprescription drug development process. SETTING: Data from consumer studies are essential for many nonprescription drug approvals. These studies are conducted to help predict actual consumer behavior in the marketplace if the product is approved. They test whether potential consumers understand a label (label comprehension study), can properly decide if a product is appropriate for them to use (self-selection study), and can use a product in accordance with the label (actual use study). The design and interpretation of these studies often pose unique challenges. CONCLUSION: Consumer studies are often part of a nonprescription drug development program. Continued efforts to improve consumer research should result in greater access to safe and effective nonprescription drug products for the American public.

An overview of the pediatric medications for the symptomatic treatment of allergic rhinitis, cough, and cold.

Upper respiratory infections and allergic rhinitis are common diseases in children. In recent years, U.S. Food and Drug Administration has been promoting pediatric drug development with marketing exclusivity incentives and requirements. The assessment of clinical pharmacology, efficacy, and safety data has facilitated pediatric drug development and provided appropriate labeling for pediatric use. Regulatory decision making involves multiple evaluation processes, including drug exposure comparison between adult and pediatric population, formulation bridging, dose selection, and evaluation of efficacy and safety in pediatric patients. This article reviews the pediatric drugs indicated for cough, cold, and allergic rhinitis, focusing on the utility of clinical pharmacology, safety, and efficacy data in determining the pediatric dosing regimen and the approaches taken for regulatory decision making.