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European Union regulatory system to be model for US?

This article was originally published in Clinica

Executive Summary

After years of trying to make minor adjustments in the US Food & Drug Administration device approval process, agency critics are now urging that drastic changes be made. The result could be a US system similar to that of the European Union, reports Clinica's Washington correspondent, Duffy Miller a public-private partnership, with health officials responsible for setting the rules and accredited third-party test houses (under government supervision) ensuring that companies comply with them.





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