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

Indiana Statutes

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

Indiana·Title 16 HEALTH·Art. 42 REGULATION OF FOOD, DRUGS, AND·Ch. 26 Drugs: Investigational Drug, Biological Product, or

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.

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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.

Indiana § 16-42-26-2 ("Investigational drug, biological product, or device") — published by Counsel Stack Legal Research, free access to 12M+ legal documents.