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Federal law requires that a drug be the subject of an approved marketing application (i.e. an application for Food and Drug Administration (FDA) approval to market or sell the drug) before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The Investigational New Drug (IND) application is the means through which the sponsor technically obtains this exemption from the FDA.
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
The FDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer) has screened the pharmacological activity and acute toxicity potential of the drug in animals and wants to test its diagnostic or therapeutic potential in humans.
There are three IND types:
- An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
- Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
- Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.