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# Guide on Minimal Residual Disease Biomarkers
- URL: https://www.fdaweb.com/guide-on-minimal-residual-disease-biomarkers/
- Published: 2020-01-27T12:00:00.000Z
- Updated: 2026-09-14T16:00:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145931

*Federal Register* notice: FDA has made available a final guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials. FDA says that a marketing application analysis showed inconsistent quality of MRD data and it decided to provide the guidance to improve regulatory submissions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-27/pdf/2020-01312.pdf?ref=fdaweb.com).