| Reference | Description |
|---|---|
| Data on File | Document containing information that is not in the public domain. |
| Government/Authority Report | Reports or guidelines issued by authorities. |
| Important Safety Information (ISI) | ISI. Important safety information will typically contain the name of the drug, approved uses for the drug, and the risks and side effects of the drug. |
| Instructions for Use (IFU) | IFU. Primarily for medical devices, instructions for use are information provided by the manufacturer to inform the user of a device’s intended purpose, proper use, and any precautions. |
| Labeling | Prescription labeling documentation that identifies the contents of the drug and provides specific instructions and warnings regarding its administration, storage, and disposal. Includes Patient Information Leaflet (PIL), Package Insert, Patient Information, Prescribing information (PI), Medication Guides, and SMPCs. |
| Monograph | A detailed document created to explain the approved use of the drug and contains any other information that may be required related to the drug. This could also be called Product Monograph and Monograph/Dossier. |
| Publication | A clinical or scientific study available in a publication. May include the full article and/or the abstract. This could also be called Clinical Articles, Clinical Guidelines, Clinical Material, Clinical Study, Clinical Study Report, Clinical Trial Report, Clinical Trials Report, Literature Reference, Abstract, Text, and Textbook. |
| Website | A website that is used for substantiation. |