investigational new drug

An investigational new drug application, almost always called an IND, is the formal permission slip a company submits to a regulator before it can give an experimental drug to people. Until it is cleared, the law in most countries forbids shipping an untested drug across borders to clinical sites. The IND is the door between the laboratory world and the human-testing world.

The submission is a dossier rather than a single form. It bundles together the preclinical pharmacology and toxicology data, a description of how the drug substance is made and controlled (its chemistry, manufacturing, and controls), and a detailed protocol for the proposed first clinical study, including the starting dose and the safety monitoring plan. The regulator reviews this within a fixed window — in the United States, thirty days — and may place a clinical hold if it sees an unacceptable risk to the first volunteers.

The term is specific to the United States Food and Drug Administration, but every major jurisdiction has an equivalent gateway: the European Union uses a clinical trial application, and other agencies have their own filings. The common idea is that no one tests a new molecule in humans without a regulator first looking at the safety case. An IND is permission to begin, not an endorsement that the drug works.