When an investigational new drug (ind application is in effect what does it permit a sponsor to do)

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.

Three IND Types

Research IND is 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 IND allows 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. The Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to 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 designated Pre-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.

Learn more on the FDA process

Obtaining Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) is the first step towards beginning your clinical trials in the United States. Getting here required hard work and a great Pre-IND Meeting strategy, but you still need FDA approval on your IND application before you can ship your drug across state lines and begin clinical trials.

The sooner you can begin your clinical trials, the sooner your product will be on the market. To prevent any hiccups in this process, your final IND submission must be error-free and contain all required information including animal pharmacology and toxicology studies, manufacturer and investigator information, along with detailed protocols for your upcoming clinical trials.

No matter where you are in the IND application or submission process, our IND consultants can provide guidance to assist with the remaining steps. Contact our IND consultants to learn more and get started today, or read on for additional information about IND applications and submissions.

Contact Us

What is an IND?

An Investigational New Drug Application (IND) is a request for authorization submitted by a Sponsor to the FDA so the Sponsor can conduct clinical trials for unapproved drugs. The purpose of an IND application is to allow Sponsors to start conducting clinical trials on humans, and approval to ship the drugs across state lines in order to conduct these trials.

Types of INDs

INDs fall into two categories, commercial INDs and research INDs:

• Commercial IND: Commercial INDs are used when the Sponsor intends to bring the drug to the open market. This means commercial INDs can apply to drugs created by non-profit groups who intend to eventually put the drug on the open market. The application process and timeline for a Commercial IND is much longer and more complex than for a Research IND.
• Research IND: Research INDs are used when the intention is to prove efficacy for a new indication of an already approved drug. Research IND applications are submitted by physicians, and with a process that is less complex than Commercial INDs. For example, Research INDs typically involve fewer investigators and are often done at a single testing site.

How to Submit an IND Application

Your IND application will request authorization from the FDA to administer an investigational drug/biological product to humans and must be approved before you transport your product across state lines to clinical sites. The requirements for an IND submission are complicated and can be hard to understand. For example, Commercial IND applications must be submitted through the FDA’s Electronic Submissions Gateway, while Research IND applications can be submitted in paper-form to the relevant address. This is just one example of the complexities within the IND application and submission process.

As such, working with an experienced IND consultant the help ensure you’re equipped and on track. ProPharma Group will work with you to make sure your IND application meets the FDA’s stringent IND filing requirements and contains all of the necessary components.

IND Filing Requirements

Each IND application should include the following:

• Form FDA 1571 (IND application cover letter)
• Form FDA 1572 (Investigator’s statement)
• Form FDA 3674 (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)
• Table of contents
• Introductory statement
• General investigational plan
• Investigator’s brochure
• Protocol(s): study protocol(s), investigator data, facilities data, Institutional Review Board (IRB)
• Chemistry, manufacturing, and control (CMC) data, including environmental assessment or claim for the exclusion (assuming the draft of CMC information exists)
• Nonclinical: pharmacology and toxicology data
• Clinical: previous human experience
• Additional information to support the IND filing

Together, we will carefully review the IND application, and our staff will provide you with a final copy that is FDA ready. The IND application will go into effect 30 days after the FDA receives the application (unless subject to a clinical hold), or earlier if the agency notifies the Sponsor that clinical trials can begin.

Get Expert Guidance From an IND Consultant for Your Upcoming Submission

ProPharma Group will guide you through every step of the IND submission process and ensure your application is error-free to meet filing requirements and ensure a successful interaction with the FDA. To learn more about how ProPharma Group can help you develop a successful IND application for submission to the FDA, contact us today.