Geoff LeCain

Answer: The term “Pass Validation” refers to a submission that has successfully been loaded into the FDA’s system. When a submission file has errors that do not allow for it to upload into the FDA’...

The application allows for the generation of a new REMS Set ID. The “Generate New REMS Set ID” button should only be used in rare circumstances when a new SetID needs to be created. Previously ele...

The “View Associated Product Listings” link is used to view all products in the data repository associated with the specific labeler.

The “submission type” tab allows company administrator to define company specific submission types. Submission types are used for reporting purposes only. Some examples of commonly used submission ...

The “Sample Packages” tabs allows users to search and manage sample packaging for products in the SPL Portal product repository.  Enter the first 3 letter of the product name to retrieve a list of...

Answer: Passing Submission files will receive an Acceptance Confirmation Receipt(a .txt file) through the Gateway /ESG. If you do not receive an Acceptance Confirmation, or you do not receive a Sec...

The “Product Submission History” tab displays all of the submissions that have been created for the selected product.   Here you can create new submissions by clicking "Request New Submission" to ...

The “Registrants” tab provides the ability to view and create registrants in the data repository. It also provides users with the ability to generate Establishment Registration submissions. To ed...

The “Distributors” tab provides the user with the ability to search, add, and manage distributors. Click on a row in the distributor’s grid to update the distributor name and status.  To create a ...

Answer: A Third acknowledgement through the gateway will notify you by email that error(s) have been received.  "This is a notification email informing you that an Error response has been received ...