H.R.5249 - Safe Overseas Human Testing Act107th Congress (2001-2002)
|Sponsor:||Rep. Lantos, Tom [D-CA-12] (Introduced 07/26/2002)|
|Committees:||House - International Relations|
|Latest Action:||House - 07/26/2002 Referred to the House Committee on International Relations. (All Actions)|
This bill has the status Introduced
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Summary: H.R.5249 — 107th Congress (2001-2002)All Information (Except Text)
Safe Overseas Human Testing Act - Declares it is the policy of Congress to control the export of drugs and other test articles intended for overseas clinical investigations involving human participants in order to foster public health and safety, prevent injury to U.S. foreign policy, and preserve the credibility of the United States as a responsible trading partner.
Introduced in House (07/26/2002)
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.