Treatment IND

Treatment IND

Treatment IND or treatment investigational new drugs, is a 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. 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. [ [http://www.fda.gov/cder/handbook/treatind.htm Treatment IND ] ] 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. [ [http://www.fiercebiotech.com/topics/treatment_IND.asp Treatment IND News - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News ] ]

References

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


Wikimedia Foundation. 2010.

Игры ⚽ Нужна курсовая?

Look at other dictionaries:

  • Industrial water treatment — can be classified into the following categories:* Boiler water treatment * Cooling water treatment * Wastewater treatmentWater treatment is used to optimize most water based industrial processes, such as: heating, cooling, processing, cleaning,… …   Wikipedia

  • cruel and inhuman treatment — As ground for divorce, consists of unwarranted and unjustifiable conduct on part of defendant causing other spouse to endure suffering and distress, thereby destroying peace of mind and making living with such spouse unbearable, completely… …   Black's law dictionary

  • cruel and inhuman treatment — As ground for divorce, consists of unwarranted and unjustifiable conduct on part of defendant causing other spouse to endure suffering and distress, thereby destroying peace of mind and making living with such spouse unbearable, completely… …   Black's law dictionary

  • pharmaceutical industry — Producers of pharmaceuticals, substances used in the diagnosis, treatment, and prevention of disease and the modification of organic functions. The earliest records of medicinal plants and minerals are those of the ancient Chinese, Hindu, and… …   Universalium

  • Glossary of clinical trials — A glossary of terms used in clinical trials. NOTOC CompactTOC8 side = yes refs = yes A * Activities of daily living:: The tasks of everyday life. These activities include eating, dressing, getting into or out of a bed or chair, taking a bath or… …   Wikipedia

  • Food and Drug Administration — FDA redirects here. For other uses, see FDA (disambiguation). Food and Drug Administration Agency overview Formed 1906 …   Wikipedia

  • U.S. Food and Drug Administration — Infobox Government agency agency name = Food and Drug Administration parent agency = logo width = 200px logo caption = FDA Logo formed = 1906 [cite web|url=http://www.fda.gov/centennial/|title=FDA Centennial 1906 2006|accessdate=2008 09… …   Wikipedia

  • Irritable bowel syndrome — This article is about a functional disorder. For bowel inflammation, see Inflammatory bowel disease. Irritable bowel syndrome Classification and external resources ICD 10 K58 ICD 9 …   Wikipedia

  • Criticism of the Food and Drug Administration — Numerous governmental and non governmental organizations have criticized the U. S. Food and Drug Administration of either over or under regulation. The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health …   Wikipedia

  • List of AIDS-related topics — This is a list of AIDS related topics, many of which were originally taken from the public domain U.S. Department of Health Glossary of HIV/AIDS Related Terms, 4th Edition. [http://www.aidsinfo.nih.gov/ed resources/glossary/] NOTOC A AACTG… …   Wikipedia

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”