Aleon’s eCTD Team Submits 3 INDs in One Day

November 2022

3 investigational new drug applications

On November 30th, 2022, our eCTD team faced a worthy challenge as they worked to submit three Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) in a single day. This was no small feat, as the IND submission process is complex and time-consuming. Our team, composed of experienced regulatory affairs professionals and former FDA employees, worked tirelessly to prepare the necessary documentation and ensure that each application was complete and accurate. Preparing three INDs for submission in one day is challenging for several reasons. First and foremost, the sheer volume of information that must be included in an IND application can be overwhelming. Each application requires extensive data on the safety and effectiveness of the investigational drug, as well as detailed information on the manufacturing process and the proposed clinical trial. Additionally, the FDA has strict requirements for the format and organization of the information contained in an IND application. Any deviation from these requirements can result in delays or even the rejection of the application. This means that our team had to carefully review each application to ensure that it met all of the FDA’s requirements. Finally, the process is not complete once the eCTD team successfully submitted the applications. Each IND submission then triggers the 30 day review period FDA, during which our team keeps close communication with the FDA and must be ready to quickly and accurately respond to questions from authorities on all three projects. Despite these challenges, our eCTD team was able to successfully submit all three IND applications on the same day. This accomplishment is a testament to the team’s hard work and dedication to ensuring the success of our investigational drugs. Looking ahead, our team will continue to work closely with the FDA to move these INDs through the review process and bring these potentially life-saving drugs to patients in need.