Geoff LeCain

Answer: Yes, the FDA needs to be able to trace where a product is manufactured in the event that something happens, needs to be recalled, etc…

The Content Editor Structure Tree allows users to view the major sections of a document.  The structure tree lists every section of the Content of Labeling/Package Insert in order of appearance inc...

Answer: Each license is taken with each individual product and not by each submission.

When viewing the Draft/Checked-out version of the document, the right-hand pane displays the content of the section that is currently selected on the left-hand pane.  Several Content Editor icons ...

Answer: Not unless they share the same Source NDC code. The likelihood is both products have different Source NDC codes so you will have to do two different listings. The product must also have dif...

After creating a new product, a user must select an FDA labeling type (red box) as well as a template (blue box) before entering any content for the label.  The template defines the sections of th...

Answer: You would list the most dominant flavor and type out the whole flavor in the text box. In the example image below you would select “strawberry” and type “strawberry kiwi” in the text box as...

The Image Manager allows a user to insert images in a document as well as manage images that were uploaded to the server.  NOTE: Using the Copy/Paste function to insert images into documents will ...

Answer: You are allowed an unlimited number of users. Administrators have access to create new users in the Portal.

Before an image can be inserted into a document, it must first be uploaded to the SPL Portal server. Once uploaded, the image name and file size will appear in “Filename” column in the image explor...