FDA OTC "material time, material extent" tentative criteria includes foreign marketing data.
This article was originally published in The Rose Sheet
Executive Summary
FDA OTC "MATERIAL TIME, MATERIAL EXTENT" TENTATIVE CRITERIA INCLUDES FOREIGN MARKETING experience to qualify a specific "condition of use" for consideration under the OTC monograph system. The long-awaited notice, published in the Federal Register Oct. 3 as an advanced notice of proposed rulemaking, begins the process of amending the agency's statutory definition of what constitutes marketing to a `material extent' and `for a material time' for reviewing new OTC conditions of use such as ingredients, indications, routes of administration and dosage forms under a monograph.