美国FDA 指导原则 开发用于治疗或预防的药物和生物制品 英文原版.pdf

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) February 2021 This document supersedes the guidance of the same title issued on May 11, 2020. Clinical/Medical COVID-19: Developing Drugs and Biological Products for Treatment or 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 and/or Office of Communication, Outreach, and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010; Email: ocod@ /vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics- guidances