FDA Finalizes 2018 Guidance on Use of Minimal Residual Disease

On Jan. 24, the U.S. Food and Drug Administration (FDA) finalized guidance to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials for treating specific hematologic malignancies. Accordinng to the Regulatory Affairs and Profesisonal Society, the guidance discusses technology that can detect the persistence of malignancy at "orders of magnitude below the limit of conventional morphological detection." 

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