美国FDA 指导原则 机构审查委员会(IRB)审查个别患者在新冠肺炎公共卫生应急指南和临床研究人员指南期间扩大对研究药物和生物制品的准入请求 英文原版.pdf

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators This guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that date. For further information, refer to 88 FR 15417, March 13, 2023, available at /documents/2023/03/13/2023-05094/guidance- documents-related-to-coronavirus-disease-2019-covid-19. Contains Nonbinding Recommendations Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators June 2020 U.S. Department of Health and Human Services Food and Drug Administration Oncology Center of Excellence (OCE) Office of Good Clinical Practice (OGCP) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Contains Nonbinding Recommendations Preface Public Comment This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. 371(h)(1)(C