FDA’s Office of Prescription Drug Promotion (OPDP) announced today that it has issued draft guidance addressing when company use of interactive promotional media constitutes promotional labeling or advertising under the Food, Drug, and Cosmetic Act. In this long-awaited document, OPDP sets forth a proposal for company submission of such materials “at time of first use,” as required by 21 CFR 314.81 and 601.12. Links to the draft guidance and the related Federal Register Notice follow.

Draft Guidance

Federal Register Notice