HR 5249 107th Congress House International Affairs Agriculture and Food Civil Rights and Liberties, Minority Issues Clinical trials Commerce Congress Congressional reporting requirements Drugs Dyes and dyeing Electronics Export controls Food additives Foreign Trade and International Finance Health Human experimentation in medicine Human rights Medical supplies Pharmaceutical research Science, Technology, Communications

Safe Overseas Human Testing Act

Introduced: July 26, 2002 See on congress.gov

Everywhere this bill has been 2 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Jul 26, 2002

Referred to the House Committee on International Relations.

Jul 26, 2002

Introduced in House

Plain-English summary Congressional Research Service

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.

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.

What's happening now July 26, 2002

Referred to the House Committee on International Relations.

Committees of jurisdiction 1