An adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information. Any event that is not expected, in

It sets out the agreed usage of the drug in the USA and provides information for healthcare professionals on the drug’s usage, efficiency and safety.

An adverse reaction whose nature, severity, specificity, or outcome is not consistent with the description given in product labelling or market authorization (USPI in the

Any reaction not mentioned in the official approved product information is unlabeled (otherwise it is termed labelled).

A clinical study that lacks a comparison (i.e., a control) group. Source: NCI

A universally unique identifier (UUID) is a 128-bit label used for information in computer systems. Ex: 123e4567-e89b-12d3-a456-426614174000 In eCTD EU dossiers, the UUID is linking

A unique ingredient identifier (UNII) is an alphanumeric identifier linked to a substance’s molecular structure or descriptive information and is generated by the Global Substance