qualifying clinical trial
(2) Qualifying clinical trial defined (A) In general For purposes of this subsection and subsection (a)(30), the term “qualifying clinical trial” means a clinical trial (in any clinical phase of development) that is conducted in relation to the prevention, detection, or treatment of any serious or life-threatening disease or condition and is described in any of the following clauses: (i) The study or investigation is approved, conducted, or supported (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 Healthcare Research and Quality. (IV) The Centers for Medicare & Medicaid Services. (V) A cooperative group or center of any of the entities described in subclauses (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 subparagraph (B) are met: (aa) The Department of Veterans Affairs. (bb) The Department of Defense. (cc) The Department of Energy. (ii) The clinical trial is conducted pursuant to an investigational new drug exemption under section 355(i) of title 21 or an exemption for a biological product undergoing investigation under section 262(a)(3) of this title . (iii) The clinical trial is a drug trial that is exempt from being required to have an exemption described in clause (ii). (B) Conditions For purposes of subparagraph (A)(i)(VII), the conditions described in this subparagraph, with respect to a clinical trial approved or funded by an entity described in such subparagraph (A)(i)(VII), are that the clinical trial has been reviewed and approved through a system of peer review that the Secretary determines— (i) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health; and (ii) assures unbiased review of the highest scientific standards by qualified individuals with no interest in the outcome of the review.