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- Investigational New Drug Application (IND)
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Investigational New Drug Application
What is an Investigational New Drug Application (IND)? An Investigational New Drug Application is the initial documentation required by the FDA in the clinical trial process. It is used to seek an exemption for any experimental product or drug that does not yet have marketing approval for transportation across state lines and use in human clinical trials. The response time from the FDA receiving the application is 30 days, during which the sponsor must wait before initiating the clinical trial.
Types of INDs
INDs include commercial INDs submitted by sponsors that are corporate entities or a part of the NIH, and research INDs submitted by sponsors who are individual investigators or academic institutions.
Depending upon the need and urgency of the investigation, there are three types of IND that may be submitted.
- Investigational IND, which is submitted by the physician who is initiating and conducting the investigation.
- Emergency use IND seeks approval for using an investigational product or unapproved drug in emergent clinical situations. They are also used for situations where the patient needing the treatment does not meet protocol criteria, or if no protocol currently exists.
- Treatment IND seeks approval for early use of the experimental drug in serious or life-threatening clinical situations while the clinical research is ongoing and the FDA approval has not yet been granted.
Components of the IND
The FDA requires specific information and format for the IND that they will review before granting approval. These components of the IND include:
- Cover sheet containing information regarding the sponsor or their representatives, phases of clinical investigation, commitment to following all regulatory requirements, and a signature of the sponsor or authorized representative.
- Table of contents.
- Introduction to the drug and general investigational plan.
- Investigator’s brochure.
- Study protocol.
- Chemistry, manufacturing, and control information.
- Pharmacology and toxicology pre-clinical data.
- Previous human experience.
- Additional supporting information.
Source: Center for Drug Evaluation and Research. (2022, July 20). Investigational New Drug (IND) Application. U.S. Food and Drug Administration. Retrieved August 22, 2022, from https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application#FDA%20Guidances%20for%20Investigational%20New%20Drugs