The US Food and Drug Administration (FDA) provides guidance to pharmaceutical and medical device manufacturers about distributing information on unapproved uses of their products. In 2009, the FDA released what is commonly referred to as “Good Reprint Practices.“* The FDA recognized that off-label or unapproved uses could be important to the standard of clinical care and to health care providers knowledge.
The guidelines were meant to outline how this information should be disseminated, through what types of publications, and how the information should be qualified. The ultimate goal was to allow companies to share scientific research about unapproved uses without promoting these uses. Continue reading How drug and device companies should distribute scientific literature about unapproved uses