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In the United States, Federal law requires that a drug or biologic product be the subject of an approved marketing application before it is transported across state lines. Before the sponsor (the individual or entity that is responsible) for the clinical investigation of a drug ships the drug to investigators in another state, they must seek exemption from that legal requirement. An Investigational New Drug application, filed with the US Food and Drug Administration is the means through which the sponsor obtains such an exemption. |
