To access each of the instructional recordings listed below, click the title for each topic:

1. Create an e-Portal Account: This will provide an overview of creating an account in the CDER OMQ e-Portal
2. Log Into the e-Portal: This will provide an overview of logging into the CDER OMQ e-Portal.
3. View and Provide Responses to Submissions: This will provide an overview of how to view and submit responses between the firm and FDA.
4. Upload a Large File: This will provide an overview of how to upload large files (up to 40GB) to include with a submission.

For additional information regarding the CDER OMQ e-Portal, please reference the CDER OMQ e-Portal User Guide. The user guide can be accessed via the Help button on the FIS website.