The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This draft guidance is intended to assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug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 the treatment of specific hematologic malignancies.
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Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hematologic Malignancies: Regulatory Considerations f...
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83 FR 52225
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“Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability,” thefederalregister.org (October 16, 2018), https://thefederalregister.org/documents/2018-22436/hematologic-malignancies-regulatory-considerations-for-use-of-minimal-residual-disease-in-development-of-drug-and-biolog.