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IVAT Proposal Drafters Consider Alternatives, Faced With FDA Reservations

This article was originally published in The Gray Sheet

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Executive Summary

Industry's in vitro diagnostic analytical test (IVAT) premarket proposal is unlikely to advance in its current form

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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