Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We have been submitting labeling in SPL format in our submissions to CBER, but in a recent approval letter we were still asked to provide paper copies of carton and container final printed labeling.  Is this an old template, or do the actually still want these paper copies?  I thought they were trying to do away with paper!
Please share your experiences, thanks.

Hi there,

I found another thread on RegEx that contains similar information that might be helpful to you: Paper/Electronic Submission

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Heather Arkwright
Community Manager
RAPS
regex@raps.org
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Original Message:
Sent: 12-Apr-2018 09:37
From: Anonymous Member
Subject: Paper copies of FPL to CBER?

This message was posted by a user wishing to remain anonymous

We have been submitting labeling in SPL format in our submissions to CBER, but in a recent approval letter we were still asked to provide paper copies of carton and container final printed labeling.  Is this an old template, or do the actually still want these paper copies?  I thought they were trying to do away with paper!
Please share your experiences, thanks.

Dear A:

At the time of First Use, you are required to submit SPL format per 21 CFR 601.14 and also paper copies* of the revised carton and container final printed labeling per 21 CFR 601.12(f).

*: three (3) original paper copies

David

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Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
http://www.GlobalComplianceSeminar.com
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US
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Original Message:
Sent: 12-Apr-2018 09:37
From: Anonymous Member
Subject: Paper copies of FPL to CBER?

This message was posted by a user wishing to remain anonymous

We have been submitting labeling in SPL format in our submissions to CBER, but in a recent approval letter we were still asked to provide paper copies of carton and container final printed labeling.  Is this an old template, or do the actually still want these paper copies?  I thought they were trying to do away with paper!
Please share your experiences, thanks.

I have recent experience with this, and I do not recommend also submitting the paper copies. I believe this request from FDA is carryover from an old letter template.

We received a letter from CBER in October 2017, which included a request for submission of final content of labeling in SPL format and also to submit three original paper copies for carton and container final printed labeling. Last month I submitted both an eCTD sequence and paper copies. I received a rejection notification for the paper submission stating that as of May 5, 2017, CBER will no longer accept paper submissions.

I did attempt to follow up with our FDA PM and DMPQ, but I have not received a response.

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Jennifer Knicley
Director Regulatory Affairs
United States
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Original Message:
Sent: 12-Apr-2018 09:37
From: Anonymous Member
Subject: Paper copies of FPL to CBER?

This message was posted by a user wishing to remain anonymous

We have been submitting labeling in SPL format in our submissions to CBER, but in a recent approval letter we were still asked to provide paper copies of carton and container final printed labeling.  Is this an old template, or do the actually still want these paper copies?  I thought they were trying to do away with paper!
Please share your experiences, thanks.