Biomarkers In Labeling Lack Clinical Utility Evidence
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA-approved labels for more than 100 drugs feature pharmacogenomic biomarker data, but only one-sixth of those biomarkers are supported by data showing a clear association with health benefits, a JAMA study found. Researchers recommend stricter standards and a standardized pharmacogenomics section of labeling.
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