An Investigational New Drug Application or Submission in Canada and the United States to conduct a clinical trial in healthy human volunteers or patients. An IND Application must include an Investigator's Brochure or synopsis of all data pertaining to pre-clinical studies, proposed clinical trials to be conducted, and a complete chemistry and manufacturing document.

A document filed with the FDA prior to clinical trial of a new drug. It gives a full description of the new drug, where and how is manufactured, all QC information, etc. The IND is followed by NDA (New Drug Application).

An application submitted to FDA by any person or company for permission to conduct clinical research on an unapproved drug. If approved, the IND exempts the sponsor from the FDCA prohibition against shipping unapproved drugs in interstate commerce for the study or studies specifically described in the IND application.

An application submitted by a sponsor to the FDA prior to human testing of an unapproved drug or of a previously approved drug for an unapproved use.

Investigational new drug application authority given by the FDA following application to test drug products in patients