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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for treating specific hematologic malignancies.
The use of MRD as a biomarker in drug development is distinct from FDA’s requirement for investigating, clearing, or approving an in vitro diagnostic device for clinical use in measuring MRD. Manufacturers interested in developing a specific MRD assay for clinical use should consult the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health (CDRH).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-3090.