Investigational New Drug [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 312.3 [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter D Drugs for Human Use; Part 312 Investigational New Drug Application; Subpart A General Provisions], 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.”