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Pharmacogenomics: Promises and Problems

Executive Summary

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.

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Recent clinical developments in the medical device industry, including developments in Artificial Limbs, Tissue-Engineered Therapy for ACL Tears, using Genes to Identify Early Atherosclerosis, and Stem Cell News.

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FDA is near to issuing revisions to its draft guidance on pharmacogenomics.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

Forging a Path for Pharmacogenomics at the FDA

The FDA is now sorting through public comments on draft guidance the agency issued recently, to encourage drug developers to voluntarily share pharmacogenomic data with it. Companies have some serious concerns that the agency means to address by the summer with the issuance of formal guidelines and the launching of a public forum for discussion about pharmacogenomics.

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