What is a Drug Label?

A drug label is the approved language denoting approval of a drug by a specific regulatory body such as the FDA or EMA. The label contains information on the approved indication, dosing, safety warnings, adverse events, contraindications, pregnancy use guidance, and so on. It also contains data from key clinical trials and other studies including data on pharmacokinetics, toxicology, etc. It also includes information on safe storage and use.

The regulatory label is very important to a pharmaceutical company and the opportunity they have in increasing uptake of the drug in the real world as it can set boundaries on what marketing materials can be developed and what commercial field teams can speak about with customers. Internal review committees often contain experts from the Regulatory Affairs organization who assess potential marketing materials to ensure alignment with the approved labeling in the country.

It is common to have differing labels across the world with each regulatory body having its own requirements and processes in assessing and approving drugs and label expansions/updates.