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  • 1.  Labeling eCTD Structure

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jul-2023 13:36
    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 (draft labeling text) or (Final Labeling Text)? Is there a guidance that provides how this should be done?

  • 2.  RE: Labeling eCTD Structure

    Posted 01-Aug-2023 08:48


    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, 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 Walsh
    Regulatory Affairs, Associate Director
    Danbury CT
    United States