Article: Guidance On Acceptance Of Foreign Clinical Studies Released By FDA : Ethical principles clarified, public comments requested.

Article: FDA guidance on foreign clinical studies
The Journal of Nuclear Medicine;  May 1, 2001 ;     533 words ... ... reaffirmed that FDA regulations ... acceptance of foreign clinical studies in support ... 1), the FDA will accept a foreign clinical study not conducted ... note that the "FDA is currently ... acceptance of foreign clinical studies, to ...

Article: PhRMA Statement On Foreign Clinical Trials
Targeted News Service;  February 19, 2009 ;     700+ words ... ... with the Food and Drug Administration (FDA)-in other countries to educate potential ... seeking U.S. approval must maintain the FDA's high standards for conducting the trial ... conducted outside the U.S. must comply with FDA requirements covering Good Clinical Practices ...

Article: Are medical product clinical trials conducted outside the US ...
Medical Design Technology;  November 1, 2001 ;     700+ words ... ... In particular, "in 1990, 271 of these foreign clinical investigators were in the FDA's database. By 1999 the number grew to 4,458. FDA inspections of foreign clinical investigators conducting drag research have ...

Article: Increasing FDA Oversight Over Clinical Research.(U.S. Food ...
Mondaq Business Briefing;  November 5, 2004 ;     700+ words ... ... Though the FDA has significant ... solely on foreign clinical data must ... Previously, the FDA required assurances that any foreign clinical trial not ... Second, the FDA believes that ... developed in foreign clinical studies ...

Article: FDA Updates Oversight, Encourages Innovation
Applied Clinical Trials;  December 1, 2006 ;     700+ words ... ... ethical standards in foreign clinical studies not conducted ... Linda Tollefson, FDA assistant commissioner ... who reports to FDA Associate Commissioner ... acceptance of data from foreign clinical trials, which ... a final rule on foreign clinical data, Lepay is ... collaborate ...

Article: FDA Oversight Of Clinical Trials.( Food and Drug ...
Mondaq Business Briefing;  October 23, 2007 ;     700+ words ... ... Report recommended five steps the FDA should take to improve its monitoring ... clinical trials regulated by the FDA Create an Institutional Review ... delegation to subordinates and use of foreign clinical trial sites Findings To support ... management limitations inhibit the FDA's ability to ...

Article: FDA, Defense Department Share Data to Enhance Medical ...
M2 Presswire;  August 3, 2007 ;     700+ words ... ... drug studies performed prior to FDA approval involve about 1,000 ... benefit alone." The DoD and FDA will meet later this year to ... event reports, and domestic and foreign clinical trials. For more information: FDA-DoD Memorandum of Understanding ...