United States Prescribing Information; USPI Translation
United States Prescribing Information (USPI) sets out the agreed usage of the drug. It provides information on usage for healthcare professionals, also known as the drug product label, prescription drug labeling, product insert, package insert, professional label, direction circular or package circular. It is an intrinsic part of the application for marketing authorization of a new drug or medicine within the United States. The USPI is typically the last step of the drug development process. It is a key mechanism to communicate to prescribers such benefit-risk information in the form of codified claims of clinical efficacy, measures of safety and risk management, and guidelines on appropriate dosage.