To download the FDA eSubmitter software, click on the following link. Save the installation zip file to your computer and extract the jinstall.exe file. Double-click the jinstall.exe file to run the installation. Follow the instructions provided in the installation wizard.
- Download eSubmitter Software (64-bit compatible only)
- Download User Manual (Updated November 6, 2020)
- Download Quick Guide (Updated March 30, 2023)
- Download eSubmitter FAQ (Updated March 30, 2023)
- Download Most Common Issues (March 2023)
Persons with disabilities having problems accessing the PDF files may call 1-877-CTP-1373 for assistance.
- Windows Operating System
- 64-bit system required
- Mac Install Instructions
- Adobe Acrobat Reader v5.0 or greater (for attaching files)
- Software capable of viewing HTML, such as a Web browser, Microsoft Word or Adobe Acrobat (full install version, not the Reader)
- 30 MB of disk space
Before installation, uninstall any other versions of the eSubmitter software. If you do not have a prior version of eSubmitter, proceed to installing the current version of FDA eSubmitter.
To uninstall the previous versions of eSubmitter, use Windows Explorer to navigate to the eSub folder of the installed drive (e.g., C:). Then, double-click on the uninstall.exe and follow the instructions provided. (If you do not see uninstall.exe, locate and double-click to open the JExpress file folder. Then, double-click on the uninstall.bat and follow the instructions provided.)
To install the latest version of the FDA eSubmitter software, navigate to the software's download directory and double-click on the jinstall.exe. Following the instructions of the installer, the FDA eSubmitter software will be installed locally.
If you're using a proxy server to connect to the Internet, then you will need to change the application's properties file (eSubmission.properties) to reference the server. See your System Administrator for help in changing the properties file. The properties file is located in the application's JExpress subdirectory (Program Files\eSubJExpress).
Add the following switches before the -cp switch:
-DproxySet=true -DproxyHost= [proxy_host] DproxyPort = [proxy_port]
(replace [proxy_host] and [proxy_port] with the appropriate information for your configuration).
If the proxy server requires a user id and password, add the following two properties to the update.control file that's also located in the JExpress subdirectory:
To launch FDA eSubmitter, go to the Start menu and select Programs>FDA Submissions Software>eSubmitter.
NOTE: If your computer is locked because of administrator privileges, you will have issues receiving automatic updates to the FDA eSubmitter software. See your System Administrator.