美国FDA 指导原则 豁免IRB对药物和生物制品研究的要求资料单 英文原版.pdf

Information Sheet Guidance For Sponsors, Clinical Investigators, and IRBs Waiver of IRB Requirements for Drug and Biological Product Studies Additional copies are available fro m: Office of Good Clinical Practice Office of Special Medical Programs, Office of Medical Products and Tobacco Food and Drug Administration 10903 New Hampshire Avenue WO32-5103 Silver Spring, MD 20993 (Tel) 301-796-8340 (Fax) 301-847-8640 /oc/gcp/guidance.html U.S. Department of Health and Human Services Food and Drug Administration January 2006 Updated October 2017 Information Sheet Guidance For Sponsors, Clinical Investigators, and IRBs Waiver of IRB Requirements for Drug and Biological Product Studies Note: FDA made the following updates to this guidance in October 2017. • The last paragraph of Section V was deleted to clarify that a sponsor does not need to apply for a waiver of local IRB review when a centralized IRB review process is used. • New Section VIII When Is An IRB Waiver for Individual Patient Expanded Access Use Of An Investigational Drug Appropriate? was added. U.S. Department of Health and Human Services Food and Drug Administration January 2006 Updated October 2017 Contains Nonbinding Recommendations Information Sheet Guidance