FDA, CMS Joint Guidance On Studies Using Cancer Biomarkers Sought In Bill
Executive SummaryFDA and CMS are directed to jointly develop guidelines on clinical studies relating to cancer care and treatment biomarkers in legislation (S. 717) introduced by Sens. Ted Kennedy, D-Mass., and Kay Bailey Hutchinson, R-Texas, on March 26
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Aetion is also working with the US Food and Drug Administration and a number of biopharma companies on projects involving use of real-world evidence.