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# Guide on Circulating Tumor DNA Drug Development
- URL: https://www.fdaweb.com/guide-on-circulating-tumor-dna-drug-development/
- Published: 2022-05-04T12:00:00.000Z
- Updated: 2026-09-14T17:43:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151738

*Federal Register* notice: FDA is making available a draft guidance entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.” The document is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid as a biomarker in cancer clinical trials conducted under an IND or to support drug/biologic marketing application for treating solid tumor malignancies in early-stage settings. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-03/pdf/2022-09459.pdf?ref=fdaweb.com).