ABSTRACT
Food and Drug Administration (FDA) regulations promulgated in 1987, to provide a more rapid formal pharmaceutical approval mechanism than the usual IND (Investigational New Drug) regulatory approval process. Its purpose is to enable drug developers to provide promising experimental drugs to patients suffering from immediately life-threatening diseases or certain serious conditions (e.g., acquired immune deciency syndrome, or AIDS) before complete data on that drug’s efcacy or toxicity are available. See also IND, Food and Drug Administration (FDA), Delaney clause, Koseisho, Committee for Proprietary Medicinal Products (CPMP).
