美国FDA 指导原则 使用说明.人类处方药和生物制品的患者标签.内容和格式 英文原版.pdfVIP

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Office of Combination Products (OCP) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2022 Labeling nl.docx Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format 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