Investigational New Drug

Similar procedures are followed in the European Union, Japan, and Canada due to regulatory harmonization efforts by the International Council for Harmonisation.

If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42.

About half of the INDs fail in preclinical and clinical phases of drug development.

It stopped accepting new patients in 1992 after public health authorities concluded there was no scientific value to it, and due to President George H. W. Bush administration's desire to "get tough on crime and drugs."

[3] Sanctioned by Executive Order 13139, the US Department of Defense employed an anthrax vaccine classified as an investigational new drug (IND) in its Anthrax Vaccine Immunization Program (AVIP).