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An Entity of Type : prov:Entity, within Data Space : webisadb.webdatacommons.org associated with source dataset(s)

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  • For purposes of paragraph (f)(2) of this section, information will be considered newly acquired if it consists of data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analys
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