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# Covid IRB Expanded Access Guidance
- URL: https://www.fdaweb.com/covid-irb-expanded-access-guidance/
- Published: 2020-06-03T12:00:00.000Z
- Updated: 2026-09-14T16:17:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146915

FDA has issued an immediately-in-effect guidance, *Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the Covid-19 Public Health Emergency*, to apply to IRB review of only individual patient expanded access INDs. The document does not apply to emergency INDs, intermediate-size INDs for intermediate-size populations, or “treatment” INDs for larger populations.

The guidance contains recommendations on IRB procedures and factors to consider for individual patient expanded access requests.