A major outreach effort is under way that recruits scientific and technological expertise in industry and academia to optimize regulatory decision-making for next-generation diagnostic tests.
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Gottlieb, S., Woodcock, J. A regulatory perspective on in vitro diagnostics. Nat Biotechnol 24, 927–929 (2006). https://doi.org/10.1038/nbt0806-927
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DOI: https://doi.org/10.1038/nbt0806-927