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Regulatory Affairs Medtech
US regulators unveil plan to transform FDA to global agency
24 June 2011
Donna Young

The US Food and Drug Administration has unveiled a ten-year strategy for transforming itself from a domestic agency working in an international world into a global agency capable of addressing product issues that arise around the world.

The 36-page "Pathway to Global Product Safety and Quality" plan1, released on 20 June, explains that the FDA plans to achieve this transformation by "developing an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships"...

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