21 CFR 312.81 - Scope.
This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.
(a) For purposes of this section, the term “life-threatening” means:
(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and
(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.
(b) For purposes of this section, the term “severely debilitating” means diseases or conditions that cause major irreversible morbidity.