16-42-26-2. "Investigational drug, biological product, or device"

IN Code § 16-42-26-2 (2019) (N/A)
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Sec. 2. As used in this chapter, "investigational drug, biological product, or device" means an investigational or experimental:

(1) drug;

(2) biological product; or

(3) medical device;

that has successfully completed Phase I of a federal Food and Drug Administration approved clinical trial, but has not been approved for general use by the federal Food and Drug Administration and remains under investigation in a clinical trial.

As added by P.L.2-2015, SEC.3.