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Waiting for New Words on Pharmacogenomics

FDA is near to issuing revisions to its draft guidance on pharmacogenomics. The biggest issues center around how to validate emerging biomarkers. The update should: further define the process for using markers in an NDA; call for a new genomics advisory committee; define the role of the committee that will look at voluntary submissions in the aggregate; and add clarity to the preferred data format for voluntary submission. The agency is expected to sidestep the issue of different standards for treating non-clinical and clinical biomarkers.

The US Food and Drug Administration is near to issuing revisions to its widely discussed draft guidance on pharmacogenomics, four months past the end of the comment period. They are expected sometime before the end of July, when FDA will hold a workshop on tandem pharmaceutical/diagnostic development. The biggest issues not addressed in the draft center around biomarkers: how to take emerging markers and give them enough validation to support their use. (See "Forging a Path for Pharmacogenomics at the FDA," IN VIVO, March 2004 Also see "Forging a Path for Pharmacogenomics at the FDA" - In Vivo, 1 March, 2004..)

The updated guidance should address four industry concerns, says Christopher Webster, director of regulatory strategy and intelligence at Millennium Pharmaceuticals...

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