What does the term "label expansion" refer to?

Label expansion refers to the process of adding new indications or uses to an existing product's labeling. This typically occurs when additional clinical data becomes available that supports the safety and efficacy of a medication for a condition not previously included in its labeling. By expanding the label, manufacturers can provide healthcare providers and patients with more comprehensive information about the potential uses of the drug, thus facilitating greater access to treatment for various conditions.

This process is crucial in regulatory affairs as it often involves submitting new data to regulatory bodies, like the FDA, to obtain approval for the expanded use. It reflects ongoing research and evolving understanding of a product's capabilities, and ideally, it enhances patient care by introducing a drug's benefits for broader health issues.