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US industry revives interest in alternative reg route for IVDs (in vitro diagnostics)

This article was originally published in Clinica

Executive Summary

US industry is eying the FDA's new "critical path" initiative as an opportunity for reviving a proposal for a less rigorous premarket category for in vitro diagnostic products. Roche and other diagnostic companies had initially floated a proposal for an in vitro analytical test (IVAT) that would not require evidence of clinical utility. It would be a way of getting promising products, like gene chips, on the market more quickly, they have argued.

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