FDA's recommendation that no "mixing" of formats should take place within a module implies that Modules 3, 4, and 5 should be internally consistent as regards format, however, they are mutually exclusive. In other words, no going back-and-forth within a module. If Module 3 is in CTD format, you should not file amendments within that module in non-CTD format.
Since the eCTD will soon be mandatory - for BLAs/NDAss (late 2015) and INDs (late 2016), BMFs/ANDAs will soon follow 2 years later, I would suggest that your next amendment be in CTD format, and where you have the time, resubmit the non-CTD documents in CTD format to harmonize your module. This will make the conversion to eCTD easier later on. The coverletter should also clearly explain what you are doing; and remember to contact the parties cross-referencing your BMF of the changes being made.
Feel free to contact me if you have additional questions.
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Marilyn Rodriguez
Associate Director, Global Regulatory CMC
Berkeley Heights, NJ
United States
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Original Message:
Sent: 05-25-2015 11:23
From: Michael Hellerstein
Subject: Format for Master File amendment
I have taken over management of a Type II Biologics Master File. All submissions have been on paper. The original submission was in CTD format, and all subsequent amendments have been in non-CTD format.
I need to submit some stability and manufacturing information, and I am unclear as to whether I should submit it in CTD or non-CTD format.
The 2001 "General Considerations" guidance on CTD format says that, "You should not mix the CTD and older formats in the same module." I am not clear as to whether this statement applies to a single module in a single submission or a single module in the entire file.
Can anyone provide some advice?
Thank you very much!
- Mike Hellerstein
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Michael Hellerstein
GeoVax, Inc.
Smyrna GA
United States
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