Geoff LeCain

If you have previously Checked-out a version for editing, and you select the Draft/Checked-Out radio button, the latest draft version is displayed in UPDATE mode in the bottom panes and its conten...

The “Authorized Agents” tab displays all authorized agents that are associated with Blanket No Change Certification Product Listings reports.  This tab also provides users with the ability to gener...

Answer: The FDA has started the process of uploading OTC Final and OTC Not Final products onto the Daily Med. The FDA has uploaded backlogged submissions and will now upload any future submissions ...

If you select the Previous Version radio button and pick a version from the list, its content is displayed in READ ONLY mode in the bottom panes of the screen and it cannot be changed.  The status ...

Blanket No Change Product Listing Files/Blanket No Change Certification Files are maintained under the Authorized Agent's tab of the Contacts/Entities Section. Selecting the Authorized Agents tab d...

Answer: 1000K or 1MB

The Section Action button is available only when viewing the Checked-out/Draft version of the document.  It has 2 options: Move/Re-Order Section Reset All Section GUIDs

The “Importers” tab provides the ability to view and create importers in the data repository.   To edit an existing Importer, click on the Importer’s name in the table and make modifications as n...

Answer: A manual override is when your submission receives a validation error that you believe is incorrect and needs to be manually placed into the system. To request a manual override, you will n...

The “Move/Re-order Sections” feature allows users to move section of a document.  The sections of a document are listed in a tree format in the left pane at the bottom of the screen. The “Move/Re-...