Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry

Issue Date: January 24, 2020
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final

Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry

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).

Download the Guidance Document