An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy.
The term also includes biological products that are used in vitro for diagnostic purposes. An IND application is a request for authorization from the FDA to administer an investigational drug or biological product to humans.
On this page:
Three IND Types
Research INDis for a physician who both initiates and conducts an investigation and the drug is administered or dispensed under his or her immediate direction. A physician might propose to study:
- an unapproved drug;
- an approved product for a new indication; or
- in a new patient population.
Emergency Use INDallows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND. It also is 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 that show promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
Two IND Categories
- Commercial
- Research (non-commercial)
Waiting 30 days
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. This allows the FDA to review the IND and ensure that research volunteers will not be subjected to unreasonable risk.
Questions
For questions regarding an Investigational New Drug application, contact
Lynn Jagodzinski Phone: (716) 888-4843
How do we complete an IND application?
The FDA has a website designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations or other organizations interested in bringing a new drug to market. ThePre-Investigational New Drug Application (IND) Consultation Programfosters early communications between sponsors and new drug review divisionsto provide guidance on the data necessary to warrant IND submission.
The review divisions are organized generally along therapeutic class and can each be contacted using the designatedPre-IND Consultation List (PDF - 19KB).
More information on the FDA’s IND process can be found on the FDA website: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm
How much time does it take to complete an IND application?
The goals of the IND are to provide enough information so FDA reviewers can approve or not.
In the IND application, researchers must include:
- Animal study data and toxicity data
- Manufacturing information
- Clinical protocols (study plans) for studies to be conducted
- Data from any prior human research
- Information about the investigator
Due to the amount and complexity of the data required for an IND application, it can take several weeks to complete. Therefore, we advice you to begin working on an IND submission as early as possible.
Notes / Additional References
When developing your study budget, please be aware that there may be charges for the storage, dispensing and accountability of study medications. Contact the Clinical Research Office.
UB School of Pharmacy and Pharmaceutical Sciences provides many services that may be useful to investigators requiring advanced pharmacy services. Check the complete list of support options.
The worksheet that IRB reviewers use to assess IND submissions is located in the Click portal, in the IRB Library section under the “Worksheets” tab. It is called “HRP-306-Worksheet-Drugs.” Reading this worksheet may help you understand the criteria and level of detail needed for the IRB and/or FDA to make a determination.
