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.
(c) Sponsors are encouraged to consult with FDA on the applicability of these procedures to specific products. [53 FR 41523, Oct. 21, 1988, as amended at 64 FR 401, Jan. 5, 1999]