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.

Source

21 CFR § 312.3

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Scoping language

The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:

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