investigational new drug (IND)
Applications and Submissions
Obtaining Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) is a critical step towards beginning your clinical trials in the United States. Getting here required hard work and a great Pre-IND Meeting strategy (which we can help manage), and 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.
Fill out the form on the right to contact our IND consultants to learn more and get started today!
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 to conduct these trials.
Types of INDs
INDs fall into two categories:
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 FDA consultant will help assure you’re equipped and on track. ProPharma 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.
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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 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 can help you develop a successful IND application for submission to the FDA, contact us today.
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