Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

Which section does the letter for 'Request for closure' of DMF goes to in eCTD. 

thank you!

Hi,

I have not yet submitted a "Request for closure" of a DMF myself; however, according to FDA's 2019 draft "Drug Master File Guidance for Industry" (section IV. DMF Closure) it seems like it should go into Module 1.5.5 (Drug Master Files Guidance for Industry | FDA)

Best,
Beate

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Beate Schmidt RAC, MSc
Consultant Regulatory Affairs
Mannheim
Germany
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Original Message:
Sent: 29-Nov-2021 16:59
From: Anonymous Member
Subject: DMF Request for closure

This message was posted by a user wishing to remain anonymous

Hi All,

Which section does the letter for 'Request for closure' of DMF goes to in eCTD.

thank you!