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Unanticipated Adverse Device Effect (UADE)

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Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. 

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International Birth Date (IBD)

The date of the first marketing authorization for any product containing the active substance granted…

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Missing information

Gaps in knowledge about a medicinal product, related to safety or use in particular patient populations, which could…

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