In Focus: Labeling

| 01 April 2008

Labeling has long been the document that conveys years of research and testing knowledge about a product's safe and effective use to healthcare providers. Labeling has also formed the foundation for promotion and advertising claims about a product. Most labeling formats and guidelines for the US and the EU were designed many years ago and updated only recently. Updates, worldwide, are intended to simplify the labeling document, making it more user-friendly. In addition, recent regulations are designed to ensure that labeling fully informs physicians and patients about a product's correct use. In the US, these regulations require structured product labeling (SPL) format, requiring certain drugs to include a patient package insert in a specific format utilizing consumer-friendly language. In the EU, package leaflet readability and understanding must be formally assessed prior to product approval. This issue of Regulatory Focus provides a closer look at the EU's requirements and the processes professionals should employ in user testing and working with the regulatory bodies.


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