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US/EU agree to continue reg talks:

This article was originally published in Clinica

Executive Summary

Meeting on June 14-15, the EMEA and the US FDA agreed to expand current co-operative activities in several areas after reviewing the past year's activities that have a common or shared interest. While the immediate focus of their plan, whose overall goal is the promotion of public health, reducing regulatory cost and burden and costs and speeding innovations into circulation, is very much pharma, vaccines and pharmacogenomics, the FDA said that regulatory co-operation would be extended to devices and cosmetics, saying "discussions on these topics will continue". Industry will, however, be mindful that the EU/US devices MRA has foundered for lack of impetus, and that as a model, the GHTF is not universally popular (see this issue, pp 6-9).

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