investigational new drug (IND)

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. Radiofilum Pharmaceutical 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.