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Little Red Riding Hood and the Big Bad Wolf Revisited

Little Red Riding Hood and the Big Bad Wolf Revisited

The story of Little Red Riding Hood is used to describe the difference between content and structure, and to establish medical writers as the source of content. Content and structure are inherently different concepts, but are often mistakenly perceived as the same, despite being generated by personnel in different departments and playing a different role in submission documents. Content, as described in this article, is generated by medical writers and is the text (or document) that supplies meaning. It is the way we describe our product’s safety, efficacy, and functionality to each other, to the regulatory agencies, and eventually to the general public. Structure is the table of contents or backbone that holds the content and defines organization within a document, or for a group of documents. Structure is generated by information architects and technologists. Both content and structure are essential to regulatory documentation, as most content generated requires structure for navigation and review. The volume of regulatory content is overwhelming without structure, and structure without content lacks sufficient meaning for the purposes of product description.