Hi,
They (the word/pdf files) are placed in the draft section until the supplement is formally approved. The approval letter will instruct:
As soon as possible, but no later than 14 days from the date of this letter, submit, via FDA automated drug registration and listing system (eLIST), the content of labeling in structured product labeling (SPL) format, as described at FDA.gov, that is identical to the enclosed labeling (text for the Prescribing Information, Instructions for Use, and Medication Guide).
I update the SPL in the final labeling section in the eCTD as part of the annual report. As I understand it, only SPL files should be in the final labeling section.
You could ask your FDA project manager to confirm or for specific instructions. It is possible that different divisions do things slightly differently.
Robyn
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Robyn Walsh
Regulatory Affairs, Associate Director
Danbury CT
United States
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Original Message:
Sent: 31-Jul-2023 12:44
From: Anonymous Member
Subject: Labeling eCTD Structure
This message was posted by a user wishing to remain anonymous
For new marketing applications/prior approval supplements (labeling supplements), when the FDA and a company agree upon the label, would you place the final labels in section 1.14.1.3 (draft labeling text) or 1.14.2.3 (Final Labeling Text)? Is there a guidance that provides how this should be done?
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