Nebraska § 71-9602 Terms, defined

Nebraska Statutes

§ 71-9602 — Terms, defined

Nebraska·Ch. 71 Public Health and Welfare

For purposes of the Investigational Drug Use Act:

(1)Advanced illness means any progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of federally approved and available treatments, and that, without life-sustaining procedures, would likely result in death within six months;

(2)Eligible patient means a person who meets the requirements of section 71-9603 ;

(3)Health care provider has the same meaning as in section 71-7907 ;

(4)Investigational drug, biological product, or device means any drug, biological product, or device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the United States

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For purposes of the Investigational Drug Use Act:
(1) Advanced illness means any progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of federally approved and available treatments, and that, without life-sustaining procedures, would likely result in death within six months;
(2) Eligible patient means a person who meets the requirements of section 71-9603 ;
(3) Health care provider has the same meaning as in section 71-7907 ;
(4) Investigational drug, biological product, or device means any drug, biological product, or device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial approved by the United States Food and Drug Administration;
(5) Physician means any person who is licensed to practice medicine and surgery pursuant to the Medicine and Surgery Practice Act; and
(6) Written, informed consent means a writing which conforms to section 71-9604 .

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