The FDA IND Application Process: 7 Tips from an Expert

By Elise Yang and Shelly Fehr

An Investigational New Drug (IND) application is submitted to the FDA to request authorization from the FDA to administer an investigational drug to humans. An IND is often needed for clinical studies with a new drug, a new method of use, new patient population, or in combination w/another approved or investigational product. The pre-IND development phase with the application process can be tedious and lengthy. First time submitters may especially find this time challenging. Below are 7 tips from an expert to help guide you through this process.

  1. Develop an Investigational Plan:

    • Identify all study and investigational drugs and devices in your protocol(s)

    • Determine if your study is exempt from the need for an (IND) application (see US CFR 21 CFR 312.2)

    • List all study supporting documents

    • Determine what further studies, documentation and data are needed

    • Determine what regulations, guidelines, and standards apply

      • Additional FDA regulations may apply; ex, HCT for cell product

      • Other government regulations may apply; ex, DEA, EPA, USDA

    • Determine the activities and associated timelines; project management is important

  2. Know Your Product(s): A study may include combinations of multiple drugs and devices. Determine your product types and identify how they are regulated. It is beneficial to research similar trials that are being done elsewhere and to collaborate with colleagues.  The supporting data from similar trials and/or similar products may advance your development, saving time and money. Websites, such as and the World Health Organization clinical study database, provide information on existing products and trials.

  3. Take Advantage of Academic Resources: Many universities have institutions and/or faculty dedicated to assisting and supporting clinical and translational research. These resources are often free of charge and may be used as a valuable resource throughout the development and the application process.

  4. Choose your sponsor wisely: The sponsor is the holder of the IND. For complex time-consuming trials, consider having the academic institution be the IND applicant. This allows the Investigator the time to focus on Investigator activities. In addition, the Academic Institution may have qualifications to be an IND holder. Inventors may start their own small company and Sponsor an IND application. A drawback to doing this is regulatory guidance is costly to a small start-up company but academic institution guidance is at a low or no cost to academic Sponsors. Thus, it is important to carefully consider all options and the pros/cons associated when determining who should hold the IND.

  5. Engage with the FDA: The FDA encourages individuals to interact with the Agency. You will need to file a formal pre-IND meeting request to discuss your topics and questions with the FDA. Though doing this may be time-consuming, it will allow you to build a relationship with the FDA early on, gain valuable feedback, and possibly move the IND through the process more quickly. Additionally, The FDA’s Center for Drug Evaluation and Research (CDER) has a Small Business and Industry Assistance (SBIA) which provides guidance, workshops, and webinars to help navigate the regulation of human drug products.

  6. Plan Ahead: The application submission can take days or months to complete depending on your product, protocols, and associated regulations. The length of the application may be as short as a few pages or as long as several hundred pages. The application is composed of non-clinical, clinical, CMC/Quality, and safety data/documentation. It is important to allot enough time for each portion of the application. Include all support documentation, including non-clinical study reports. These animal and bench tests (study may include devices) can be expensive. Determine when full GLP compliant facilities are necessary. It is important to manage time and costs in the development and application phase.  

  7. Think Globally: Don’t limit your market to the U.S. only. Consider your target population and the costs and time to conduct trials in various countries. Canada, Europe, Japan, China, and India are some of the regions with big markets for drugs and will study participants. If you decide to focus on a region outside the U.S., research how countries in that region regulate drugs and clinical trial applications, as requirements usually differ.

These 7 IND tips will help to plan and manage your study development and application process.

Elise Yang is a student in the Chemical and Biomolecular Engineering department at the University of Pennsylvania |
Shelly Fehr is the Director of the Sponsor Support Unit in the Office of Clinical Research in the Perelman School of Medicine at the University of Pennsylvania.

Back to the homepage

Photo by Glenn Carstens-Peters on Unsplash