- Docket Number:
- Docket No. FDA-2022-D-0084
- Issued by:
Guidance Issuing OfficeOncology 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.” This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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.