What does the term "labeling" exclude in drug regulation?

The term "labeling" in drug regulation refers to all information that is provided with a drug product, which often includes the label on the immediate packaging, as well as any accompanying written or visual material that conveys necessary information about the drug's use, administration, and safety to the healthcare provider and patients.

In this context, prospective clinical trial data is not considered part of labeling. Labeling focuses on information that is meant to be used during healthcare practices and provides guidance on the safety and efficacy of the drug based on approved usage. It typically does not include data obtained from clinical trials that have not yet been completed or evaluated for regulatory approval. This prospective data might be used in discussions with regulatory bodies or for future research but is not disseminated as part of the product's labeling to healthcare professionals or patients at the time of the drug's approval or market release.

In contrast, visual aids included in packaging, instructions for safe and effective use, and written materials associated with the drug are integral components of labeling as they provide critical information about how to properly use the drug, including indications, dosages, warnings, and potential side effects.