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# Guide on IRB Reviews of Expanded Access Requests
- URL: https://www.fdaweb.com/guide-on-irb-reviews-of-expanded-access-requests/
- Published: 2020-06-02T12:00:00.000Z
- Updated: 2026-09-14T16:16:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146913

FDA has posted a [guidance](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20publishes%20guidance%20for%20IRBs%20and%20clinical%20investigators&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=13628&elqTrackId=5137353F466B1C0D05C0C1A95B8A494F&elq=03ec09f492a945f4813ae22e289c1) entitled “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.” The agency says the document is intended to address a “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.” FDA also says it is aware that IRBs seek clarification on the key factors and procedures to consider when they review requests for individual patient EA, including reviews conducted by a single member of an IRB. Additionally, the guidance recommends 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.