Clinical investigation

Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

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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