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Nature Biotechnology 26, 599 (1 June 2008) | doi:10.1038/nbt0608-599b
FDA gets personal
Abstract
New guidelines published by the US Food and Drug Administration (FDA) bring the prospect of personalized medicine a giant step closer. The document, released in April, aims to ensure that consistent definitions of key terms in pharmacogenomics are applied across the US, Europe and Japan, the three regions covered by the International Conference on Harmonization, a project gathering together regulatory authorities and pharma experts.
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