ABSTRACT
An Investigational New Drug Application (IND) is a submission to the U.S. Food and Drug Administration requesting permission to initiate a clinical study of a new drug product in the U.S. The Federal Food, Drug, and Cosmetic Act (the Act) requires that all drugs have an approved marketing application (NDA, BLA, ANDA) before they can be shipped in interstate commerce. From a legal perspective, the IND is a request for exemption from the Act’s prohibition from introducing any new drug into interstate commerce without an approved application. The IND allows you to legally ship an unapproved drug or import the new drug from a foreign country.
