Institutional Review Board Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products; Guidance for Institutional Review Boards and Clinical Investigators; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for institutional review boards (IRBs) and clinical investigators entitled "Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products." FDA is issuing this final guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under FDA regulations. Although FDA has issued guidance on expanded access requests, including expanded access for individual patients, the Agency is aware that IRBs seek further clarity on this topic.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.