This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices) that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling (sometimes collectively referred to in this guidance document as “promotion”) of their FDA-regulated medical products on electronic/digital platforms that are associated with character space limitations—specifically on the Internet and through social media or other technological venues (Internet/social media). Examples of Internet/social media platforms with character space limitations include online microblog messaging (e.g., messages on Twitter or “tweets,” which are currently limited to 140 character spaces per tweet) and online paid search (e.g., “sponsored links” on search engines such as Google and Yahoo, which have limited character spaces as well as other platform-imposed considerations). This draft guidance presents considerations to illustrate FDA’s thinking on factors that are relevant to the communication of benefit and risk information on Internet/social media platforms with character space limitations.


Posted on the FDA website on 19 June 2014