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

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  • compliance with the FDA's GCP, or EU legislation governing GCP, including the failure to pass FDA, EMA or EU Member State inspections of clinical trials; ?? the FDA or other regulatory agencies may change their approval policies or adopt new regulations; ?? adverse medical events during the trials could lead to requirements that trials be repeated or extended, or that a program be
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