U.S. Investigational New Drug Application → IND Components
The IND application must contain information in three broad areas:
- Animal Pharmacology and Toxicology
- This can also include any previous human studies the drug has evidence for, such as if the drug has been studied/approved in another country.
- Manufacturing Information–composition, manufacturer, stability, and controls used for manufacturing
- The manufacturer must prove they are able to produce the drug product consistently across batches.
- Detailed Clinical Protocols and Investigator Information
- The clinical protocols primarily cover whether the initial clinical trials will place the participants at unnecessary risk.
- The investigator information is required to assess if the primary investigator(s) is/are qualified to perform the clinical trial.
- The IND must also include commitments to adhere to FDA regulations for investigational new drugs, such as obtaining informed consent and obtaining review of the study by an institutional review board (IRB).
Who can file an IND?
Clinical investigations are initiated by sponsors. Sponsors can be an individual, commercial entity, organization, or government agency, and the sponsor takes responsibility for the conduction of the study.
Most INDs are filed by noncommercial sponsors, such as a sponsor-investigator, rather than commercial sponsors, such as a pharmaceutical company. Typically these individual investigators are studying already approved drug products either in a new indication or a new patient population.
When is an IND not required?
An IND is not required if an FDA approved drug is being studied within its FDA approved labelling/indication. Another scenario would be if the study was utilizing a placebo, as long as the investigation does not require an IND otherwise.
Other cases that may allow an exemption from an IND include studies involving cancer treatment, in vitro diagnostic biological products, blood grouping serum, reagent red blood cells, and anti–human globulin.