This guidance describes the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on recommended practices for drug and medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines (CPGs) that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States. For the purposes of this guidance, these materials are generally referred to as scientific and medical publications.