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
(6/2/2020) – FDA is issuing this “Guidance for IRBs and Clinical Investigators” to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.
See document here: https://www.fda.gov/media/138496/download
Categories COVID-19