Treatment IND

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Treatment IND or treatment investigational new drugs, is a United States regulation (made by the federal register, May 22, 1987) used to make promising new drugs available to desperately ill patients as early in the drug development process as possible. The U.S. Food and Drug Administration (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 in their later stage of development such as HIV/AIDS, herpes simplex encephalitis and subarachnoid hemorrhage or if there is no alternative drug or therapy available to treat that stage of the disease in the intended individuals. 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. 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.^[1] Treatment INDs are rare. For the period of 1987-1999, only 39 such applications were approved. Of these 39 experimental treatments, 13 were for cancer and 11 were for HIV/AIDS. Patient advocates and healthcare activists often push for companies to apply for Treatment INDs when they think a new drug may hold some promise to cure or treat a disease. There are many problems associated with this, however. Some examples include drug companies preferring controlled clinical trials over treatment INDs and patient costs, since insurance companies don't cover experimental treatments.^[2]

References

http://irb.mc.duke.edu/InvestigationalProducts.htm

External links

Preapproval Opportunities. Applied Clinical Trials, June 2008.
Boundaries of Expanded Access. Pharmaceutical Executive, May 2008.
A Time for Compassion. Applied Clinical Trials, September 2007.
Expanded Access to Investigational DrugsGenetic Engineering & Biotechnology News, January 15, 2010.

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