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European and US agencies will ensure ethical conduct of trials

Posted By admin On 20/08/2009 @ 04:18 pm In International News, EBM updates | No Comments

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have will work together to ensure that clinical trials related to drug marketing applications in the USA and Europe are conducted “uniformly, appropriately, and ethically.”  

The “good clinical practices initiative” is expected to strengthen safeguards for partici­pants in clinical studies. In a joint statement the EMEA and the FDA said that in most cases the same clini­cal trials are used to support applications to both agencies for approvals of new drugs. Many of the people participating in these clinical trials are recruited in

Europe and the

US
. The statement says that US and EU regulators need to ensure that trials in their 

BMJ , vol 339, 15/8/9, p362.[1] http://www.bmj.com/cgi/section_pdf/339/aug12_1/b3278.pdf


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[1] http://www.bmj.com/cgi/section_pdf/339/aug12_1/b3278.pdf: http://www.bmj.com/cgi/section_pdf/339/aug12_1/b3278.pdf

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