Geoff LeCain

The Content Editor is designed to help a user create and modify labeling content using previously defined template.  Additionally, the Content Editor can be used to modify the labeling content that...

The “Establishment Registration Files” link is used to create and download Establishment Registration files. Existing Establishment Registration submission files are listed in descending order ba...

The “ACA Submission” tab provides the user with the ability to create and download XML submissions. To create a new submission, select the “Request New Submission” link.  The user will need to pop...

Answer: Select the “Download” hyperlink to download the error message.

The application allows for one or more labeling types to be associated with a product.  The choices that appear in the labeling type list can be customized.  

The “View Associated Product Listings” link is used to view all “private label” products in the data repository associated with the specific registrant.  A product is designated as “private label” ...

Answer: You can have the Portal send you email notifications when your products have been uploaded to the NLM and you can later add additional email addresses to be copied on the notifications. Sim...

The application allows users to toggle between versions of labeling content by using one of three radio buttons: Current/Checked-In – This is the baseline version.  This version contains the most...

Answer: An SPL file must accompany all submissions that propose changes to the content of labeling, including certain amendments, submissions of final approved content of labeling and annual reports.

The Content Editor page also displays information about the Identifier, Listing and Effective date.