approved clinical trial

(1) In general In this section, the term “approved clinical trial” means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition and is described in any of the following subparagraphs: (A) Federally funded trials .— The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following: (i) The National Institutes of Health. (ii) The Centers for Disease Control and Prevention. (iii) The Agency for Health Care Research and Quality. (iv) The Centers for Medicare & Medicaid Services. (v) cooperative group or center of any of the entities described in clauses (i) through (iv) or the Department of Defense or the Department of Veterans Affairs. (vi) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. (vii) Any of the following if the conditions described in paragraph (2) are met: (I) The Department of Veterans Affairs. (II) The Department of Defense. (III) The Department of Energy. (B) The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration. (C) The study or investigation is a drug trial that is exempt from having such an investigational new drug application.


42 USC § 300gg-8(d)(1)

Scoping language

In this section
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