IND Application & Submission

Understanding IND Applications

Investigational New Drug (IND) approval is the first step towards being able to begin your clinical trials. Getting here required hard work and a great Pre-IND Meeting strategy.

The sooner you can begin your clinical trials, the sooner your product will be on the market, and in order to prevent any hiccups in this process, your final IND submission must be error free and contain all of the required information.

How to Meet IND Filing Requirements

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. The Weinberg Group will work with you to make sure your IND application meets these stringent requirements and contains all of the following components:

  • Form FDA 1571 and 3674
  • 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 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.

To learn more about how The Weinberg Group can help you develop a successful IND application for submission to the FDA, contact us today.