Dear Kesley,
Any DMF can be submitted electronically. I have experience of filing Type V DMF as eCTD.
Excerpt from FDA website: (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/UCM2007046):-
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ELECTRONIC DMFs (Category 3)
There is no requirement to file DMFs in electronic format. Paper DMFs will continue to be accepted.
The FDA has published a Draft Guidance "Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (01/03/2013) regarding electronic submissions. DMF holders are encouraged to submit their DMFs in electronic form, including updating current paper DMFs. DMFs must be in ECTD format .
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Here, we should observe that FDA has referred 'DMF'', which should be applicable for
any DMF.
For further clarification, you can reach
CDER at esub@fda.hhs.gov or CBER at esubprep@cber.fda.gov. esub is very supportive for electronic submissions.
Hope this helps.
Regards,
Shrivathsa
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Shrivathsa Achar
Manager
Biocon Limited
Bangalore
India
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Original Message:
Sent: 04-09-2014 09:23
From: Kelsey Frisch
Subject: Type IV submissions
Hi All,
Do Type IV DMF's have to be submitted electronically? Or is paper general practice.
With looking at guidances on the FDA website, it seems to only reference paper submissions for Type IVs.
Anyone have any further experience/insight?
Any and all feedback is greatly appreciated!
With Gratitude,
Kelsey
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Kelsey Frisch
Reliable Biopharmaceutical
Overland MO
United States
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