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# IRB Individual Patient Expanded Access Reviews Guide
- URL: https://www.fdaweb.com/irb-individual-patient-expanded-access-reviews-guide/
- Published: 2020-06-08T12:00:00.000Z
- Updated: 2026-09-14T16:17:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146949

*Federal Register* notice: FDA has made available a final guidance 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.” The document provides recommendations regarding the key factors and procedures IRBs should consider when reviewing requests — including when reviews are conducted by a single IRB member for an individual patient's expanded access. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-12429.pdf?ref=fdaweb.com).