Geoff LeCain

The Create SPL button is available only when viewing the Current/Checked-in or Draft/ Checked-out version of the document.  It has 4 options: The “Create SPL for FDA Submission” option generates ...

Answer: You can reuse a delisted NDC after 5 years if it meets the conditions below: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=207.35&SearchTerm=reuse "(ii) When a re...

The “Preview SPL w/ Intagras stylesheet” displays the XML content using the FDA’s stylesheet and exposes the underlying LOINC associated to sections.

The “Preview SPL w/FDA stylesheet” option displays the XML content using the FDA’s style sheet.

Answer: Only users that are defined as administrators in the application have the ability to modify user data. For administrators, navigate to the Admin page and select the “Users” tab (see image b...

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...