美国FDA 指导原则 化疗引起的恶心和呕吐开发预防药物行业指南行业指南草案 英文原版.pdf

Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 (CDER) Mary Chung at 301-796-0260. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) May 2021 Clinical/Medical ft.docx 05/14/21 Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone : 855-543-3784 or 301- 796-3400; Fax: 301-431-6353 Email: druginfo@ /drugs/guidance-compliance-regulatory-information/guidances-drugs U.S. Department of Health and Human Services