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Impact of microarray data quality on genomic data submissions to the FDA

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How can microarray data best be exploited and integrated into the regulatory decision-making process?

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Figure 1: Increase in formal requests (consults) for genomic data review (data submitted as part of regular INDs, NDAs or BLAs) to the Office of Clinical Pharmacology, and voluntary genomic data submissions (VGDS) to the FDA, since 2004.

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  1. US Food and Drug Administration, Office of Clinical Pharmacology, Center for Drug Evaluationand Research, 10903 New Hampshire Avenue, Silver Spring, 20993, Maryland, USA

    Felix W Frueh

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  1. Felix W Frueh
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Frueh, F. Impact of microarray data quality on genomic data submissions to the FDA. Nat Biotechnol 24, 1105–1107 (2006). https://doi.org/10.1038/nbt0906-1105

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