Treatment IND

Treatment IND is a mechanism in the United States that allows investigational drugs to be used for serious diseases or conditions. This mechanism is used when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition involved.

Overview

The Food and Drug Administration (FDA) allows the use of investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size patient populations under a treatment IND or treatment protocol. The primary intent of a treatment IND is to provide treatment for a disease rather than to collect data about the drug.

Eligibility

To be considered for a treatment IND, a drug must be in the investigational stage of development and not yet have received FDA approval for marketing. The drug must be intended to treat a serious or immediately life-threatening disease and there must be no comparable or satisfactory alternative therapy available. The drug's sponsor (usually the manufacturer) must be actively pursuing marketing approval.

Process

The process for obtaining a treatment IND begins with the drug's sponsor, who submits a protocol (a detailed plan of the treatment) and a supplement to the existing investigational new drug application (IND) to the FDA. The FDA reviews the protocol and, if it agrees that the drug may be effective and that its benefits outweigh its risks, it may grant a treatment IND.

See also

• Investigational New Drug
• Food and Drug Administration
• Clinical trial

Treatment IND Resources
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