Investigational new drug
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.
21 CFR § 312.3
The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part: