Prior to drugs being commercially available, manufacturers often conduct pre-clinical studies to obtain data ensuring that their drug is both safe and effective. Once the data has been collected, manufacturers then submit an Investigational New Drug Application (IND) to the Department of Food and Drug Administration (FDA). Per the FDA, “An IND is a request from a clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans”. These can be submitted for either commercial or research use. After submission, drug manufacturers/sponsors must wait 30 days to begin clinical trials.
There are 3 types of INDs:
- Investigator IND- this type is submitted by a physician who initiates the IND, conducts the investigation, and administers the investigational drug. These can be submitted to study an unapproved drug or to use an approved drug for a new purpose.
- Emergency Use IND- this type allows the FDA to authorize experimental drug use in an emergency situation where time is not allowed for submission of an IND in accordance with 21CFR, Sec.312.23 or Sec.312.20. This is also used when patients do not meet the testing criteria of an existing protocol or if an approved protocol does not exist.
- Treatment IND- this is applied to experimental drugs that show promise in clinical testing for serious or immediately life-threatening conditions. This type allows for simultaneous treatment while the final clinical work is still ongoing, and the FDA is reviewing the data.
In general, all IND’s must contain information the following information:
- Data showing that the product is reasonably safe for initial testing in humans. This is often done using animal pharmacology and toxicology studies to obtain pre-clinical data.
- Any manufacturing information about the manufacturer, compound, process controls, composition showing that company can reliably produce the drug.
- Protocols for the proposed clinical studies and information on clinical investigators to ensure they are qualified and are committed to obtain the informed consent from the studies patients, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
If you need support in submitting an IND, the experts at EMMA International can help! Call us at 248-987-4497 or email us at info@emmainternational.com to learn more.
U.S. Food and Drug Administration. (2022, October 14). Investigational New Drug Applications (inds) for CBER-regulated Products. Investigational New Drug Applications (INDs) for CBER-Regulated Products. Retrieved March 27, 2023, from https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/investigational-new-drug-applications-inds-cber-regulated-products#:~:text=An%20Investigational%20New%20Drug%20Application,or%20biological%20product%20to%20humans.
U.S. Food and Drug Administration. (2022, July 20). Investigational New Drug (IND) Application. Retrieved March 27, 2023, from https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
