What is an IND application?
What is an IND?
An IND is an investigational new drug application. When a sponsor wants to conduct experimental trials on an unapproved drug, they must receive approval to do so from the US FDA (the Food and Drug Administration).
An application is also required when researchers want to investigate existing drugs (that have already been approved by the FDA) for either a new indication or a new patient population.
In a nutshell, the purpose of the application is to obtain official permission from the FDA to ship the drug across state for clinical investigation by the person(s) named on the form. Note that the investigator ‘may not administer an investigational new drug to human subjects until the IND application goes into effect’.
Commercial IND vs. research IND
A sponsor must submit all relevant information about the drug through the relevant application form. The type of form that they should choose depends on their intentions for the clinical investigation. There are two types of applications: commercial and research (non-commercial).
- Commercial. This should be used when a sponsor (usually a corporate entity) intends to commercialise the product by eventually submitting a marketing application. They should select “Commercial IND” on FDA Form 1571 Field 6B.
- Research (non-commercial). This should be used by a sponsor (e.g., an academic scientist, a research institution or non-profit) who needs permission to research either an unapproved drug or an approved drug for: a) a new indication or b) a new patient population. According to the FDA, these studies are strictly for research and must have no commercial intent.
FDA IND application: phase 2 and phase 3 protocols
- Note that if you are submitting either a Phase 2 or Phase 3 protocol, the FDA will normally define your application as “commercial” and eCTD requirements should become applicable. The sponsor should select “Commercial” on FDA Form 1571 Field 6B: IND Type.
- However, if the sponsor is certain that the product will not be commercialised (e.g., the intent is exclusively ‘research’), they should attach an explanation of their rationale in a cover letter. In this case, they should select “Research” on the form 1571.
How to submit an FDA IND application?
Note that while commercial INDs must be submitted in electronic format via the Electronic Submissions Gateway, this rule does not apply to research INDs, which can still be submitted in paper-based format to the Central Document Room:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266
When does the IND application go into effect?
After you have sent your IND application, the FDA will send you a letter to acknowledge receipt of the application.
If your application is approved, the IND will go into effect 30 days after it has been received by the FDA. However, the authority may contact you to let you know that clinical investigations can begin earlier.
If your IND application is not approved, it will be subject to a clinical hold, which means that the proposed investigation should be delayed or suspended.
How to improve your IND application process
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Download your IND submission checklist
If you’ve found ‘What is an IND?’ useful, download your free checklist for FDA IND applications to support you throughout the process. It also provides advice on how to arrange a pre-IND meeting with the FDA.Download now