Geoff LeCain
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Recent activity by Geoff LeCain-
Submissions
The “Submissions” page provides users with a list of all submissions for all products that have been created. This page is one of two pages that can be defined as the user’s landing page. A land...
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Products
The “Products” page provides users with information about the products in the system. This page is one of two pages that can be defined as the user’s landing page. A landing page is a page that is...
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Reports
The “Report” tab allows users to create and download several canned reports. Select the type of report you would like to run from the left pane. Enter the report parameters. Note that some report...
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Templates
Templates are used as a foundation for document. A default template can be assigned to each labeling type. The “Templates” tab allows users to create new and/or edit existing templates. These tem...
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NLM Labels
The NLM Labels function allows users to search and download labels from the Daily Med. The complete set of DailyMed SPL is downloaded nightly and available for searching in the application. There ...
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ACA Samples
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...
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SPL Portal August 2021 Update
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...
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NDC Code Reservations / Reserved Marketing Status
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...
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CMO: Drug Manufactured Under Contract
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...
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Windows 11 & SPL (update Microsoft Edge settings to view XML)
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...