Accurate and reliable drug information is essential for safe and effective use of marketed products. The primary source of drug information is a package insert (PI). It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. A good PI contains approved, essential, and accurate information about the drug. It is written in a language that is not promotional, false, or misleading. It is evidence-based and updated time to time as relevant pre-clinical and clinical data become available.
Package insert, Drug