Single-Patient Expanded Access Requests: IRB Professionals' Experiences and Perspectives.

08:00 EDT 9th April 2019 | BioPortfolio

Summary of "Single-Patient Expanded Access Requests: IRB Professionals' Experiences and Perspectives."

U.S. physicians may treat a patient with an investigational drug outside of a clinical trial by using the expanded access (EA) pathway or the recently created federal right to try (RTT) pathway. The EA pathway requires physicians to get prior permission from the U.S. Food and Drug Administration (FDA) and, except in emergency cases, institutional review board (IRB) approval. The perspectives of IRB professionals on the review of single-patient EA requests have not been empirically studied.


Journal Details

This article was published in the following journal.

Name: AJOB empirical bioethics
ISSN: 2329-4523
Pages: 1-12


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Medical and Biotech [MESH] Definitions

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