Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability

May 4, 2022

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May 2022

Guidance Document

Download the Final Guidance Document

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.”  This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage setting.

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