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# Draft Guide on Hematologic Malignancies Drug Development
- URL: https://www.fdaweb.com/draft-guide-on-hematologic-malignancies-drug-development/
- Published: 2018-10-16T12:00:00.000Z
- Updated: 2026-09-15T00:38:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142588

*Federal Register* notice: FDA has made available a draft guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is is intended to assist sponsors planning to use minimal residual disease as a biomarker in clinical trials. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-16/pdf/2018-22436.pdf?ref=fdaweb.com).