United States Prescribing Information (USPI)

  • The USPI sets out the agreed usage of the drug. It provides information on usage for healthcare professionals, and is an intrinsic part of the application for marketing authorisation of a new drug or medicine within the United States. The equivalent of the USPI in the European Union is the Summary of Product Characteristics (SmPC).
  • Trilogy understands the intent and needs of the USPI and SmPC and is able to help your teams produce a document that is a consistent reflection of the data available from your clinical programme and submission dossier.