美国FDA 指导原则 扩大治疗用研究药物的可获得性.行业问答指南 英文原版.pdf

Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers 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) June 2016 Updated October 2017 Procedural Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers Guidance for Industry Add itional copies are availablef rom: Office of Communications, Division of Drug Inf ormation Centerf or Drug Evaluation and Research Food and Drug Administration 10001 New Hamp shire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3 784 or 301-796-3400; Fax : 301-431-6353 Email: druginf o@f http ://www.f /Drugs/GuidanceComp lianceRegulatoryInf ormation/Guidances/def ault.htm and/or Office of Communication, Outreach and Development Centerf or Biologics Evaluation and Research Food and Drug Ad ministration 10903 New Hamp shire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4 709 or 240-402-8010 Email: ocod@f http ://www.f /BiologicsBlood Vaccines/GuidanceComp lianceRegulatoryInf ormation/Guidances/def ault.htm U.S. Department of Health and Human Services