The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section of drug labeling, which the FDA expects to be “clear, concise, useful, and informative and, to the extent possible, consistent within and across drug and therapeutic classes.”

The draft guidance supplements current FDA regulations and guidance related to the content and format of drug labeling. The draft guidance addresses the scope of a drug’s indication relevant to specific patient populations studied, including pediatric versus adult indications. The draft guidance further provides guidance and examples regarding drafting the specific indication for a drug and the associated limitations of use, including words to avoid, such as “prevent”, “only” and “also indicated.”

It is important for drug and biologics manufacturers intending to seek FDA approval of a new or revised drug label to incorporate the principles outlined in this draft guidance. Manufacturers and other interested parties should carefully review this draft guidance and provide comments to the FDA prior to the September 7, 2018 deadline.

Posted by Sarah K. diFrancesca