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.
References
Tobin, C. Hosp. Management Int. 75–79 (2003).
McGuire, L. Cancer 36, 638–644 (1975).
Lesko, L. & Woodcock, J. Nat. Rev. Drug Discov. 3, 763–770 (2004).
Lesko, L.J. & Salerno, R.A. Pharmacogenomics 5, 503–505 (2004).
Lesko, L.J. & Salerno, R.A. Pharmacogenomics 5, 25–30 (2004).
Gutman, S. Clin. Chem. 45, 746–749 (1999).
Lesko, L.J. et al. J. Clin. Pharmacol. 43, 342–358 (2003).
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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
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