Geoff LeCain

The “ACA Samples” module allows users to search and create ACA sample submissions that can later be sent to the FDA. There are 6 tabs within the ACA Samples Search Distributions – Allows a user t...

Users now have the ability to download all attachments with a single button click SPL Portal will now have the ability to generate Establishment Deregistration files directly in SPL Portal SPL Por...

For Human and Animal Drugs and certain Biological products, NDC Code Reservation SPLs may be submitted to the FDA to reserve an NDC Manufactured Product Code for future use. NDC Code Reservation SP...

A "drug product manufactured under contract" is a drug that is manufactured by a Contract Manufacturer but is not marketed by the Manufacturer. For SPL files with the marketing category terms which...

When updating to Windows 11 you will notice Internet Explorer has been removed as an internet browser. To properly preview the XML without Internet Explorer you will need to utilize the Microsoft E...

The “Change Password” option allows users to change their current password. Passwords must follow the following rules: Consist of 8 to 20 characters Contain at least 1 letter Contain at least 1 nu...

Click the “Help” option from the “View” drop-down menu to display the on-line Help files.  The Help topics will open in a separate browser window. The help content is searchable.

If your submission has a status of “Ready to Submit” and you have added the FDA Submissions Gateway to your account, a green arrow will appear in the “Submit to FDA Gateway” column (Red Box). If y...

By default, My Checked Out Products tab is displayed when the Product page is first opened.  If the user does not have any checked out products, then the product list tab is displayed.  The My Chec...

The “Addresses” tab displays all addresses that are associated with labelers, registrants and Establishments. To create a new address, press the “Create New Address” link (red box). To edit an ...