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FDA action has harmed business, says Utah

This article was originally published in Clinica

Executive Summary

Utah Medical is feeling the impact of the recent blow dealt by the US FDA when the agency announced its intention to seek a permanent injunction against the company from selling medical devices. The decision, considered to be a particularly aggressive move by the FDA, was the latest twist in the ongoing dispute between the agency and Utah, in which the FDA claims that the company's production facility does not conform to certain federal manufacturing standards (see Clinica No 1120, p 11).

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