Geoff LeCain

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-...

The “Establishments” tab provides the ability to view, create and list all Establishment in the data repository.   To edit an existing Establishment, click on the Establishment’s name in the tabl...

Answer: The FDA is not requiring all inactive ingredients to be listed but is requesting the data be provided. If there is a UNII code for an inactive ingredient, it is expected that you include th...

The “Reset All Section GUIDs” button should only be used if the error listed below is received for a submission: “id must not match any other id across all sections, documents, or any id other th...

The “Establishment Lookup” tab allows users to search and find Establishments that have been registered with the FDA and their associated operations. Type the first three letters of the Establishme...

Answer: You can visit the following link on the FDA site that describes all acceptable types of packaging.http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicS...