<Li> Emergency Use INDs, also called compassionate use or single - patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance with 21 CFR § § 312.23, 312.24 . These are most commonly used for life - threatening conditions for which there is no standard treatment . </Li> <Li> Treatment INDs are filed to make a drug available for treatment of serious or immediately life - threatening conditions prior to FDA approval . Serious diseases or conditions are stroke, schizophrenia, rheumatoid arthritis, osteoarthritis, chronic depression, seizures, Alzheimer's dementia, amyotrophic lateral sclerosis (ALS), and narcolepsy . </Li> <Li> Screening INDs are filed for multiple, closely related compounds in order to screen for the preferred compounds or formulations . The preferred compound can then be developed under a separate IND . Used for screening different salts, esters and other drug derivatives that are chemically different, but pharmacodynamically similar . </Li> <P> The IND application may be divided into the following categories: </P>

When is a pre-ind application submitted to the fda