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Which monitoring visit would not include an inventory of investigational agents?

Ralph Lopez

in Business

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Victoria Fowler on December 28, 2018

21 CFR 812 Investigation Device Exemptions do not include an inventory of the investigation of the agents.It is a tool that is the subject of a clinical study to be used in order to collect safety and effectiveness information needed to support a pre-market approval (PMA) application or a pre-market notification.

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