Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development." This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (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 (curative-intent) setting. This guidance finalizes the draft guidance entitled "Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development" issued on May 2, 2022.
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