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Glossary

Trend reporting

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A reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred and for which pre-defined trigger levels are used to determine the threshold for reporting. 

Other glossary definitions

M

MedWatch

MedWatch is the US Food and Drug Administration’s reporting program for product complaints. MedWatch MedWatch…

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I

International Birth Date (IBD)

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

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