美国FDA 指导原则 循环肿瘤脱氧核糖核酸用于早期实体肿瘤药物开发；工业指南草案；可用性 英文原版.pdfVIP

Use of Circulating Tumor DNA for Early- Stage Solid Tumor Drug Development Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions regarding this draft document, contact Julia Beaver (OCE) at 240-402-0489. U.S. Department of Health and Human Services Food and Drug Administration Oncology Center of Excellence (OCE) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) May 2022 Clinical/Medical Use of Circulating Tumor DNA for Early- Stage Solid Tumor Drug Development Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Office of Communication, Outreach and Development Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Food and Drug Administration Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor 10903 New Hampshire Ave.,