Other Issues

CHPA strongly believes that companies should continue to utilize a set of robust metrics to drive internal continuous improvement activities to enhance product quality and ensure consumer safety.

CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.

CHPA's comments on this Draft Guidance are organized into three General Comments and Detailed Comments by Section.

CHPA supports advancing modernization of USP's quality monographs, updating and improving the compendial test methods and establishing product standards which can provide an additional measure of safety for OTC products.

Letter to Dr. Shawn Dressman regarding U.S. Pharmacopeia's Stimuli article: USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities.

CHPA supports improving the compendial test methods and establishing product standards for levels of elemental impurities which can provide an additional measure of safety for OTC products.

This report builds upon current insights with findings from a new survey which examines two important stakeholder groups and analyzes what drives these groups’ use and trust in OTC medicines.

Enclosed are comments on "Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products that Contain Acetaminophen."