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FDA RU 486 review: audit of foreign data requested in citizen petition filed by Rep. Bliley, pro-life group.

Executive Summary

FDA RU 486 REVIEW: FOREIGN DATA IN NDA MUST BE AUDITED, CITIZEN PETITION submitted to FDA Feb. 28 maintains. The petition was filed by Chicago-based "Americans United For Life" and several members of Congress including House Commerce Committee Chairman Bliley (R-Va.) and Judiciary Committee Chairman Hyde (R-Ill.). "The agency...should conduct in-depth validity audits of each foreign clinical trial relied upon by an RU 486 NDA applicant," the petition states.

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