Prescription Drug Advertisements and Product Communications

This information collection supports FDA regulations regarding prescription drug advertising. Under authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that advertisements published in journals, magazines, newspapers, or other periodicals, as well as advertisements broadcast through media such as radio, television, and telephone communication systems comply with the public health protection provisions therein. Respondents to the information collection are sponsors of prescription drug product promotional material. The information collection also includes agency guidance clarifying the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human and animal prescription drugs and prescription biological products.

The latest form for Prescription Drug Advertisements and Product Communications expires 2021-08-31 and can be found here.

Prescription Drug Advertisements Reporting Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety