Investigational New Drug Application | IND Application | Types of IND Application

 

What is an Investigational New Drug Application (IND)?

An IND is an Investigational New Drug (IND) Application defined as a document filed with the FDA prior to conducting experimental clinical trial of a new drug. The sponsor must obtain approval from the US FDA (the US Food and Drug Administration) before conducting clinical trial.

An application is also required when investigators want to investigate existing drugs (that have already been approved by the FDA) for either a new indication or a new patient population.

What Does an IND Application Contain?

In the IND application, researchers or sponsor must include: 

• Full description of the new drug

• Where and how it is manufactured (Manufacturing information)

• All quality control information

• Animal study data and toxicity data

• Clinical protocols (study plans) for studies to be conducted

• Data from any prior research involving human

• Information about the investigator/sponsor

FDA Forms Requirement

Filing an IND application requires completion of 3 sets of forms:

 

FDA Form 1571	Details the study
FDA Form 1572	Contains information regarding the investigator and study site
FDA Form 3674	Certifying that the study is registered in the national database of clinical trials

 

The IND is followed by New Drug Application (NDA).
 
Purpose of IND

The purpose of an IND is to ensure that subjects involved a clinical investigation that involves the use of a drug will not face undue risk of harm.
 
Types of IND Application
 
There are three types of IND application.

 

Investigator IND	·   It is submitted by a physician/medical doctor who both initiates and conducts an investigation ·  Under physician/medical doctor immediate direction the  investigational drug is administered or dispensed to the subject ·   A research IND can be submitted to propose studying an unapproved drug, or an approved drug for a new indication or in a new patient population
Emergency Use IND	· It allows the FDA agency to authorize use of an experimental drug in an emergency circumstances
Treatment IND	·  It is submitted for an experimental drug showing promise in clinical testing for immediately life-threatening or serious conditions while the final clinical work is conducted and the FDA review is pending.

 

Categories of IND

There are two categories of IND application:

·         Commercial	·     Research (non-commercial)
This should be selected when a sponsor (usually a corporate entity) intends to commercialise the product by submitting a marketing application.	This should be selected 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.

 

What Qualifies as an IND? 

It can take several weeks to complete the IND submission due to the amount and complexity of the data required for an IND application. Therefore, FDA advices sponsor to begin working on an IND submission as early as possible.

Investigational New Drug Approval Process

When to Initiate Clinical Trial after Submitting IND Application

·        The sponsor must wait 30 calendar days before initiating any clinical trials.

·    During this time period, FDA review the IND application for safety to assure that research subjects will not be subjected to unreasonable danger.

Summary  

Meeting the various agencies dynamic regulatory requirements for conducting drug studies is an essential part of undertaking biomedical research. Sponsor-investigator, working closely with the FDA make the process easier and all the guidance needed for filing the essential documents is comprehensive and readily accessible from the FDA Web site.

Read more: New Drug Application I Abbreviated New Drug Application I NDA I ANDA

 

Reference:

 

1. Investigational New Drug (IND) Application. Accessed from https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.  

2. Holbein ME. Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators. J Investig Med. 2009;57(6):688-94.