Geoff LeCain
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Articles
Recent activity by Geoff LeCain-
How do you know if your Gateway Submission and/or ESG Submission has passed validation?
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...
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Product Submission History
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 ...
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Registrant List
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...
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Distributors
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 ...
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How do you know when your submission has failed validation?
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 ...
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Content Editor
The Content Editor is designed to help a user create and modify labeling content using previously defined template. Additionally, the Content Editor can be used to modify the labeling content that...
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Create/View Registration
The “Establishment Registration Files” link is used to create and download Establishment Registration files. Existing Establishment Registration submission files are listed in descending order ba...
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ACA Submissions
The “ACA Submission” tab provides the user with the ability to create and download XML submissions. To create a new submission, select the “Request New Submission” link. The user will need to pop...
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How do I download my error message?
Answer: Select the “Download” hyperlink to download the error message.
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1. FDA Labeling Type
The application allows for one or more labeling types to be associated with a product. The choices that appear in the labeling type list can be customized.