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Investigational New Drug (IND) Applications and Submissions

Obtaining 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.

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.

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. ProPharma 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 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.

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