Label Enhancement

What is a label enhancement? 

Label enhancement refers to the process of updating and improving the content of a drug or medical device label to provide more comprehensive, clearer, or additional information. This may include revising safety warnings, dosage instructions, indications for use, or adding newly discovered benefits based on further clinical data or real-world evidence. The goal is to improve the clarity, accuracy, and usefulness of the product's labeling for healthcare providers and patients. 

Why is label enhancement important? 

Label enhancement ensures that medical products remain safe, effective, and relevant over time. By continually improving the information on a product’s label, it helps healthcare professionals and patients make more informed decisions, contributing to better outcomes and patient safety.