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Treatment IND
Treatment Investigational New Drugs (Federal Register, May 22, 1987) are used to make promising new drugs
available to desperately ill patients as early in the drug development process as possible. FDA will permit an
investigational drug to be used under a treatment IND if there is preliminary evidence of drug efficacy and the drug is
intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy
available to treat that stage of the disease in the intended patient population. In addition, these patients are not
eligible to be in the definitive clinical trials, which must be well underway, if not almost finished.
An immediately life-threatening disease means a stage of a disease in which there is a reasonable likelihood that
death will occur within a matter of months or in which premature death is likely without early treatment. For example,
advanced cases of AIDS, herpes simplex encephalitis, and subarachnoid hemorrhage are all considered to be immediately
life-threatening diseases. Treatment INDs are made available to patients before general marketing begins, typically
during Phase 3 studies. Treatment INDs also allow FDA to obtain additional data on the drug's safety and effectiveness.
Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.
Back to The New Drug Development Process
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