FDA issues guidance on requirements for individual requests to use COVID-19 investigational drugs

The Food and Drug Administration this week released guidance for institutional review boards seeking clarity regarding the key factors and procedures they should consider when reviewing requests by physicians and others for individual patient access to investigational drugs.

A request for emergency individual patient access to an investigational drug does not require prior IRB review, but the board must be notified within five working days once treatment begins and any subsequent use of the drug is subject to IRB review, the guidance notes.