Compassionate-use INDs

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. 

Emergency and Compassionate-use INDs and Accelerated NDA or ANDA Approvals—Procedures, Benefits and Pitfalls... 

Under some circumstances, in the USA, widespread distribution of an investigational agent prior to NDA approval, involving large-scale populations, is permitted (the treatment IND is an extension of the old compassionate use notion). Under these conditions it is, of course, necessary to monitor safety in such broader use, and usually with greater scrutiny that might ordinary apply... 

The CFR does not differentiate between the "commercial" and "non-commercial," research," or "compassionate" IND. The three general "types" of INDs below are often mentioned, but again the nomenclature used is not recognized by 21 CFR312.3. The term Commercial IND is defined in CDER s MAPP... 

Named patient basis A mode of supplying an unlicensed drug for use by a physician for a given named patient usually for compassionate grounds where the drug would not otherwise be available. Sometimes patients are allowed to continue at the end of a trial on this basis. Various regulations cover such use. Also known as treatment IND is the USA. 

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