Federal law dictates that a drug must have an approved marketing application before it can be transported across state lines (i.e., placed into interstate commerce). New drug developers almost always must deliver investigational drugs to clinical investigators across the country to conduct the studies required to obtain marketing approval, so they are compelled to request an exemption from this federal law. The Investigational New Drug (IND) application is the mechanism through which sponsors acquire that exemption from the FDA, which processes approximately 1,500 such applications every year.
The FDA’s core objectives during the IND review process are primarily twofold: to safeguard the rights and well-being of the study subjects and, particularly in Phase II and Phase III clinical trials, ensure that the design and conduct of clinical trials are sufficient for a comprehensive evaluation of a drug’s safety and efficacy.
