FDA Publishes Guidance for IRBs and Clinical Investigators During the COVID-19 Public Health Emergency - Drug Information Update

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FDA Publishes Guidance on Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During COVID-19 Public Health Emergency

On June 2 the U.S. Food and Drug Administration published the guidance titled 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.  FDA is issuing this guidance because of the substantial increase in the number of requests by physicians seeking to treat their patients with investigational drugs under the agency’s individual patient expanded access (EA) pathway during the COVID-19 public health emergency. The agency also is aware that IRBs seek clarity regarding the key factors and procedures to consider when they review requests for individual patient EA — including reviews conducted by a single member of the IRB — to fulfill obligations under 21 CFR Part 56.  The recommendations in the guidance address establishing procedures for single IRB member review in response to physician waiver requests for exemption from full IRB review, as well as factors to consider when assessing benefits and risks for a particular patient being treated under expanded access.