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.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 26. Drugs: Investigational Drug, Biological Product, or Device
16-42-26-1. Effect on Clinical Trial Laws; Availability
16-42-26-2. "Investigational Drug, Biological Product, or Device"
16-42-26-3. "Qualified Patient"
16-42-26-4. Availability of Investigational Drug, Biological Product, or Device