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I. When to use this forms form should be used to obtain concurrence from the Institutional Review Board (IRB) Chairperson of the use of an investigational device under the Food and Drug Administration\'s
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Emergency use refers to the authorization granted for the use of medical products in emergencies when no alternative treatments are available. Compassionate use is a provision that allows for the use of unapproved drugs or therapies for patients with serious or life-threatening conditions when they cannot participate in a clinical trial.
Healthcare providers or manufacturers of medical products may be required to file requests for emergency use or compassionate use programs with regulatory agencies.
To fill out an emergency use or compassionate use application, one typically needs to provide detailed patient information, the rationale for use, the specifics of the treatment, and supporting medical documentation.
The purpose of emergency use and compassionate use is to provide patients with access to potentially life-saving treatments when traditional treatment options are unavailable or ineffective.
Information that must be reported includes patient demographics, the nature of the condition being treated, details of the requested product, and the anticipated outcomes or risks associated with the treatment.
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