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 Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability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

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability May 2022

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
Docket No. FDA-2022-D-0084
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.”  This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials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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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: Docket No. FDA-2022-D-0084.

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