C2985698_NCI_FDA | Knowledge4COVID-19

Property	Value
?:definition	Life-threatening, serious and unexpected adverse events as described in 21 CFR 312.32, 600.80 and 314.80 Periodic adverse event report: Post-marketing report required by CFR 600.80 to be submitted quarterly for three (3) years, then annually, upon approval/licensing of vaccine or biologic product.
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?:type	<https://research.tib.eu/covid-19/vocab/AnnotationDefinition>

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