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Waiting for New Words on Pharmacogenomics

Executive Summary

FDA is near to issuing revisions to its draft guidance on pharmacogenomics.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.

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So far, pharmacogenomics, the study of the effects of an individual's genetic makeup on their response to drugs, has not produced the hoped-for revolution in the pharmaceutical industry, due primarily to lagging approvals and the high cost of molecular testing. Nevertheless, the promise of personalized medicine is very real, and several exciting products have received FDA approval.

The Outlook for Pharmacogenomics Testing in Primary Care

The FDA sees pharmacogenomics as a key tool for optimizing both the development and clinical utility of drugs. But most of the visible examples to date of pharmacogenomics have been in specialty areas like oncology and virology. The Vioxx situation raises an inevitable question as Pharma looks to improve R&D efficiency and clinical utility. What is the role of pharmacogenomics in assessing the safety and efficacy of primary care drugs?

The Outlook for Pharmacogenomics Testing in Primary Care

The FDA sees pharmacogenomics as a key tool for optimizing both the development and clinical utility of drugs. But most of the visible examples to date of pharmacogenomics have been in specialty areas like oncology and virology. The Vioxx situation raises an inevitable question as Pharma looks to improve R&D efficiency and clinical utility. What is the role of pharmacogenomics in assessing the safety and efficacy of primary care drugs?

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