Investigational New Drug (IND)

Investigational New Drug

USA: 21 CFR 312 – Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms “investigational drug” and “investigational new drug” are deemed to be synonymous for purposes of this part (as per 21 CFR 312.3(b))