Treatment IND

Treatment IND (or non-US regulatory authority equivalent) - as in entry 1, the investigator takes the responsibility for the trial... 

Brakel J, Davis JM. Taking harms seriously involuntary mental patients and the right to refuse treatment, ind L Rev 1991 25 429-473. 

Treatment IND inspections (information is available to CDER indicating that an inspection of a clinical supplies manufacturer is warranted to protect the health of patients)... 

This route presents not only a quick, efficient way to deliver drugs into the bloodstream but a vulnerable route for poisoning. In early 1989 the FDA gave "Treatment IND" status to an aerosol form of pentamidine for the prevention and treatment of Pneumocystis carnii pneumonia which is the most common life-threatening infection seen in AIDS patients. 

Very ill patients may receive a drug that shows promise in late clinical trials. This requires the IND to be classified as a treatment IND. Treatment IND status is valuable for critically ill patients who may not be able to wait until the drug receives full NDA approval. Related to a treatment IND is the parallel track policy. Specifically developed to help AIDS patients, INDs with parallel track classification may be administered to patients who are not healthy enough to qualify for inclusion in a phase trial. Data from parallel track patients are not included in the clinical trial data. 

Treatment IND Mechanism to provide patients with experimental products for serious or life-threatening diseases. 

Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions, while the final clinical work is conducted and the FDA review takes place. 

Requests to charge and Treatment Protocols must be submitted separately. Treatment INDs and Treatment Protocols are special cases and are not intended for single patient use. Before checking either of these boxes, the sponsor should be thoroughly familiar with the cited regulations and contact the appropriate FDA reviewing division to discuss the proposed treatment use. 

Destaillats H, Lesko TM, Knowlton M, Wallace H, Hoffmann MR. Scale-up of sonochemical reactors for water treatment. Ind Eng Chem Res 2001 40 3855-3860. 

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 immediately life-threatening diseases. Treatment INDs are made available to patients before general marketing begins, typically... 

Y. Sakata, M. A. Uddin, A. Muto, M. Narazaki, K. Koizumi, K. Murata, and M. Kaji, Spontaneons degradation of municipal waste plastics at low temperature during the dechlorination treatment, Ind. Eng. Chem. Res., 37, 2889-2892 (1998). 

O. M. Alfano, M. Vicente, S. Esplugas, and A. E. Cassano, Radiation field inside a tubular multilamp reactor for water and wastewater treatment, Ind. Eng. Chem. Res. 29, 1270-1278 (1990). 

Although the term is in common usage, Compassionate Use INDs do not exist. The Treatment IND aims to make an investigational new drug available to patients with a defined disease state that is serious (usually life threatening), and for which there is no alternative therapy. This application may be made whether or not an NDA is to be filed at a later date. 

There are several criteria which must be met for a Treatment IND to be acceptable to FDA, under 21CFR paras 312.34(b)(1)—(iv). Within these... 

Treatment INDs are thus for pharmaceutical companies, not for individual physicians. All the usual clinical hold provisions apply. 

Frequently, circumstances arise during the interval between NDA submission and approval which make it desirable for the (still) investigational drug to be made more widely available. The Treatment IND or the Emergency Use IND (21CFR para 312.36, see above) generally accommodates this need (21CFR paras 312.34 and 312.35). 

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