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Pharmacogenomics

US FDA issues companion guidance on submitting and using pharmacogenomic data

The US Food and Drug Administration (FDA) has published a new draft guidance document with recommendations for use of pharmacogenomic data in product development1. The advice contained in Pharmacogenomic Data Submissions - Companion Guidance applies to the development of data that could be used in support of investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs). It notes that applications for diagnostic devices may require additional information.

The document includes a comprehensive section setting out the methodological issues that should be considered when submitting gene expression data from microarrays. Among other things, it calls for standard operating...

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