Types of IND Applications
A potential new drug needs IND approval to enter the clinical investigation part of development. IND approval must be completed before the new drug application can be submitted for approval to market to doctors and patients. IND applications must contain three types of information:
- Toxicology study data — before going to clinical trials a drug needs to be tested in the laboratory. Data from these pre-clinical tests is included in the IND application to demonstrate the product is reasonably safe to give to people. Ultimate safety cannot be determined until clinical trials are performed, but there must be some basis for assessing risk to humans. Another piece of information that is helpful is any experience humans may have with taking the drug. This is usually data from foreign use of the drug or substances like it.
- Clinical protocols — the plan for all clinical trials is included in the IND application for FDA review. This section of the application also includes the qualifications of the professionals who will oversee the clinical trials.
- Drug production — the ingredients and production method of the drug need to be revealed in the IND application, along with its stability and any other information concerning what is in it and how it might be reproduced.
With a completed application, the FDA has up to 30 days to review this information and issue an IND. After that, clinical trials can begin.
Types of INDs
An IND is required in the development of a new drug, but there are other types of INDs issued by the FDA:
Emergency Use IND — The FDA may authorize the use of an experimental drug for patients who do not fit the study criteria or as treatment in a life-threatening situation when there is no time to wait for an IND.
Investigator IND — Submitted by a doctor for research on an un-approved drug or a new indication for an approved drug. The FDA approves the doctor who submitted this application to administer the drug and conduct the investigation.
Treatment IND — this allows an experimental drug to be used to treat a patient while the FDA is conducting its review of the drug. It is only approved for serious or life-threatening conditions.