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                FDA eSubmitter

FDA eSubmitter

                        CBER eSubmitter Program
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          FDA eSubmitter
          eSubmitter Download and InstallationFDA eSubmitter eSubmitter Download and Installation
  
  	
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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.

System Requirements

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 spaceInstallation Instructions

**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:

**proxyUserName=**
proxyPassword=

**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.

                                                                                  Content current as of:
      04/27/2023FDA eSubmitter

          
                        CBER eSubmitter Program
          CDRH eSubmitter Program
          Using eSubmitter to Prepare Tobacco Product Submissions
          eSubmitter Download and Installation
          eSubmitter Tutorial Videos
          Contact eSubmitter
          CVM eSubmitter Programs
          eSubmitter Application History
 
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