Clinical studies that experience a new drug, new method of administering that drug (as well as combining this study with another product under investigation) require an Investigational New Drug (IND) application. If you’re a submitter for the first time, here are several tips that will make the process much easier for you.
Prior to the pre-IND meeting (as well as the IND submission), it is important to assess the preclinical development data you have. Doing so will allow you to determine whether this data supports your case that the drug is safe (within reason) for human use. Most INDs (with exceptions) are submitted for the sole purpose of commercial drug development. That’s why it is important to identify all drugs and devices within your protocol, if your study is even exempt from an IND application and determine which studies and future documentation is required.
There is no reason to disassociate yourself from interacting with the FDA, which actively encourages people to interact with them. By building an early relationship, you will encounter invaluable feedback and (in rare cases) even move the IND application along the tracks in a more time efficient manner. Their Center for Drug Evaluation and Research provides guidance and workshops that help people swim the human drug product waters. There are certain IND filing services that make it easier for you to engage with the FDA.
More often than not, studies include a multiple array of combinations of multiple drugs and devices that may interfere with each other negatively. Therefore, it is crucial for you to figure out your product type and discover how they are regulated. Your development may advance due to the supporting data that arises from conducting similar trials.
Whoever holds the IND is the sponsor. Academic institutions are excellent IND application/holders for time-consuming trials that are complex and beyond the scope of your abilities. Additionally, certain academic institutions may possess specific qualifications to be an IND holder that you do not.
Do you know how many universities in your area have faculty specifically dedicated for the use of supporting (and even assisting) clinical research trials? Are you aware of how many resources, which are often offered free of charge (or free, in suspect cases)? The development and application process of submitting an IND is a systematic process. One that academic institution and/or faculty have perfected inside and out.
The regulatory project manager (RPM) at the FDA will serve as the regulatory contact once the IND is submitted. This means that the RPM will receive (and review) team assignments, directs the application to the review team – usually consisting of a chemist, toxicologist, clinician, and statistician. During this reviewal, the FDA requires that the sponsor waits 30 calendar days before executing the beginning of clinical trials. During this time, the FDA may request additional information or require detail clarification in the application.
Therefore it is important for you to ensure that your IND working team is roared and ready to discuss any questions, insights or other topics that pop up during this crucial time period. Your FDA IND will be accepted only if the research subjects will not be put at significant risk or suffer undue damages to their