Draft Guidance: Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment

The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or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. Read the full guidance here or click the image to download.

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Paul Mirek
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