Geoff LeCain
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Articles
Recent activity by Geoff LeCain-
Create/View Wholesale Distributor/3rd Party Logistics Provider Files
The “Wholesale Distributor/3rd Party Logistics Files” link is used to create and download Wholesale Distributor/3rd Party Logistics submissions files. This link will only be displayed if an Establ...
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What is the difference between XML and SPL?
Answer: XML is a specification for creating custom markup languages for sharing structured data. SPL is a standard that uses XML.
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Current/Checked-In
If you select the Current/Checked-in radio button, the content of the baseline version is displayed in READ ONLY mode in the bottom panes on the screen and it cannot be changed. If you want to mak...
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US Agents
The “US Agents” tab provides the ability to view and create agents in the data repository. To edit an existing agent, click on the US Agent’s name in the table and make modifications as needed. ...
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How many times do we need to update our listings?
Answer: You should only update your listings if there has been a significant change to the content of labeling. You are not required to update annually unless there are reportable changes made to t...
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Draft/Checked-Out
If you have previously Checked-out a version for editing, and you select the Draft/Checked-Out radio button, the latest draft version is displayed in UPDATE mode in the bottom panes and its conten...
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Authorized Agents
The “Authorized Agents” tab displays all authorized agents that are associated with Blanket No Change Certification Product Listings reports. This tab also provides users with the ability to gener...
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Why is my OTC product showing up on the Daily Med?
Answer: The FDA has started the process of uploading OTC Final and OTC Not Final products onto the Daily Med. The FDA has uploaded backlogged submissions and will now upload any future submissions ...
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Previous Version
If you select the Previous Version radio button and pick a version from the list, its content is displayed in READ ONLY mode in the bottom panes of the screen and it cannot be changed. The status ...
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Blanket No Change Product Listing Files
Blanket No Change Product Listing Files/Blanket No Change Certification Files are maintained under the Authorized Agent's tab of the Contacts/Entities Section. Selecting the Authorized Agents tab d...