With the requirement effective date to provide regulatory submissions in electronic format for nonclinical data (SEND) fast approaching both the industry and the FDA are looking to ensure that the transition is smooth. To that end, the FDA had indicated that test submissions can be made to not only aid the industry in reviewing their processes but also aid the agency with their processes as well. To date there have not been many test submission made our team will dive into the barriers that there may be associated with completing test submission as well as investigate ways to demystify the process.
To establish the barriers that are associated with this a brief survey will be sent out and from the results of this survey the team will determine what deliverables could developed to increase the number of test submissions, address the barriers and establish a forum where questions associated with the test submission process can be asked, discussed and answered. To do this the team will work with the SEND Implementation team to add space to the Advance Hub already in place.
Additional potential outputs from this team may also include a white paper, a poster at the PHUSE 2017 CSS as well as a webinar hosted by PHUSE or FDA surrounding the test submission process.
Development of a list of questions to submit to the FDA that surrounds the demystification of how they are going to use the data/information provided within these test submissions.