CT10: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

Description

An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.

The information that must be included and the format in which it needs to be presented are outlined. The process of review by the FDA is described, and the outcomes and sponsor’s responses are discussed. The actions necessary to maintain an open IND are set out.

Finally, the regulatory provisions for expanded-access use of investigational drugs are described.