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.

FDA is near to issuing revisions to its draft guidance on pharmacogenomics.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The FDA is now sorting through public comments on draft guidance the agency issued recently, to encourage drug developers to voluntarily share pharmacogenomic data with it.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.