Treatment IND

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 the desperately ill patients as early in the drug development process as possible. The U.S. Food and Drug Administration (FDA) permits investigational drugs to be used under a treatment IND, if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious disease, or life-threatening disease. A few examples include such as HIV/AIDS, herpes simplex encephalitis and subarachnoid hemorrhage, or it may be used if there is no adequate drug or therapy available to treat that degree in an intended individuals. Treatment INDs are made available to patients in need 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. Patient advocates and healthcare activists often push for companies to apply for Treatment INDs, in hope of a new drug that may hold some promise to cure or treat a disease.