Geoff LeCain

The “Create SPL for FDA Submission” option generates a full product submission package in SPL format with all associated images.  This submission package can be submitted to the FDA.

Answer: To change your password, you would simply select the Actions drop-down menu and then select Change Password. Enter a new password and enter the same password in the “Retype Password” field ...

  The “Create SPL for Review” creates files for review only.  Note that these files cannot be submitted to the FDA.

Answer: Under the Product Data Elements, simply change the “Marketing Status” to “Completed” and then enter in a “Marketing End Date”. The Marketing End Date is the date you no longer plan to marke...

This feature allows users to create renditions of the SPL in either PDF or RTF formats. The Create Rendition button is available for all versions of the document.  It has 2 options: The “PDF” opt...

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...