How the IND 30-day Hold Impacts Clinical Trial Activities
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that
IND
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.
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
As a drug successfully makes it through the development process, sponsors will inevitably need to submit a new drug application
Beginner’s Guide to Pre-IND Meetings
New to the process of helping to bring a drug to market? As intimidating as the Food and Drug Administration
Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Read about IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance.
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug