Please contact Katherine L. Ulman,
kathyulman@yahoo.com. She has extensive experience with DMFs, is an expert on DMFs, and a faculty member with us at: esubmissionsuniversity.com I am retired from the eCTD for-profit community and have no commercial or financial interest in making this recommendation.
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S. Albert Edwards FRAPS
President, eSubmissions University
Lincolnshire IL
United States
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Original Message:
Sent: 06-Aug-2020 11:57
From: Anonymous Member
Subject: DMF Submission
This message was posted by a user wishing to remain anonymous
Hi everyone
My query is regarding USDMF submission: if there is a product/ excipient with two different specifications, can we submit a single DMF only with FDA as the manufacturing process is same- the only difference is in the specifications
Please advise
Thanks in advance!