An Investigational New Drug (IND) is a drug or biological product that has not been approved for general use by the Food and Drug Administration (FDA). It is used in a clinical trial to investigate its safety and efficacy.
Types of INDs
- Commercial INDs are filed by companies to obtain marketing approval for a new drug.
- Research or investigator INDs are non-commercial INDs filed by researchers to study an unapproved drug or to study an approved drug for a new indication or in a new patient population.
- Emergency Use INDs, also called compassionate use or single-patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance with 21 CFR §§ 312.23, 312.24. These are most commonly used for life-threatening conditions for which there is no standard treatment.
- Treatment INDs are filed to make a drug available for treatment of serious or immediately life-threatening conditions prior to FDA approval. Serious diseases or conditions are stroke, schizophrenia, rheumatoid arthritis, osteoarthritis, chronic depression, seizures, Alzheimer’s dementia, amyotrophic lateral sclerosis (ALS), and narcolepsy.
- Screening INDs are filed for multiple, closely related compounds in order to screen for the preferred compounds or formulations. The preferred compound can then be developed under a separate IND. Used for screening different salts, esters and other drug derivatives that are chemically different, but pharmacodynamically similar.
How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
Q&A: The IND Journey Phase I – Navigating Success
Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success.
Common Pitfalls in Preparing an IND Application
While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.
Advarra Consulting Delivers Clinical Trial Management Oversight
Download this case study to learn how Advarra Consulting mitigated risks and enabled compliance for a medical device organization.
Beginner’s Guide to Pre-IND Meetings
This blog provides a beginner’s overview of what the pre-IND meeting is and how to prepare for one.
The IND Journey Phase I – Navigating Success
Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.
Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Learn how to ensure compliance with FDA 21 CFR 312.32, and explore Advarra solutions that support efficient and compliant safety reporting.
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an Investigational New Drug (IND) application for the first time? Consider three common CMC pitfalls that may impact submission.