FDA, EMEA to Accept Biomarker Data for Kidney Toxicity Studies | GenomeWeb
NEW YORK (GenomeWeb News) – The US Food and Drug Administration and the European Medicines Agency have agreed to accept data for seven kidney toxicity biomarkers as part of the drug approval process, the FDA said today.
 
The agencies will now accept the results of tests that measure the levels of seven proteins found in urine -- KIM-1, albumin, total protein, β2-microglobulin, cystatin C, clusterin, and trefoil factor-3 -- that are indicative of drug-induced damage to kidney cells.
 

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