To promote safe and ethical clinical trials of drugs and other test articles on people overseas.
Requires a license approved by the President for the export of such test articles. Sets forth certain export license requirements, including that the license applicant shall: (1) identify each clinical investigation for which the test article is intended; and (2) submit proof that each of the protocols for every clinical investigation has been reviewed by an institutional review board and has, at a minimum, met substantially the same standards for the protection of the rights and welfare of human subjects as that required for Institutional Review Boards approval of protocols for clinical investigations (in the United States) of test articles pursuant to the Federal Food, Drug, and Cosmetic Act.
Introduced in House
Introduced in House
Referred to the House Committee on International Relations.
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