Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Open Forum-

For the final printed labeling (the insert that is folded and placed inside the packaging), does it need to match the SPL version that was approved 100%?  I know the text, tables and figures need to be identical, but are sponsors allowed to add artwork, such as the company logo to the printed material, which is not included in the electronic version submitted with the application?

Thank you for your time.

Hi, UWtRA,

Is this a drug, device, or combination product? 

If this is a Class III device, the FDA will approve an application on the basis of draft final labeling. Read the approval letter carefully.  It will contain conditions upon which the approval is based.  One condition is usually that the applicant submits to FDA a copy of the final printed labeling before marketing.  This can be done in the form of a CBE supplement.

------------------------------
John Minier, RAC
Consultant, Principal
Minier Medical Device Consulting
john@johnminier.com
1(914)850-4432
Highland Mills, NY
United States
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Original Message:
Sent: 10-Jul-2017 14:11
From: Anonymous Member
Subject: Final Printed Labeling

This message was posted by a user wishing to remain anonymous

Dear Open Forum-

For the final printed labeling (the insert that is folded and placed inside the packaging), does it need to match the SPL version that was approved 100%?  I know the text, tables and figures need to be identical, but are sponsors allowed to add artwork, such as the company logo to the printed material, which is not included in the electronic version submitted with the application?

Thank you for your time.

In general they should match.

Ultimately, the final SPL version of your label is what is going to be used for posting on DailyMed. What is on DailyMed should really match what you have in the market.

That said - it is possible for your marketed label to have some differences from your submission labeling but these should be relatively small changes (i.e., changes that could be considered annual reportable or non-reportable).

------------------------------
Brandon Stempo RAC
Regulatory Labeling Manager
Easton PA
United StatesRegulatory Labeling Manager
------------------------------

Original Message:
Sent: 10-Jul-2017 14:11
From: Anonymous Member
Subject: Final Printed Labeling

This message was posted by a user wishing to remain anonymous

Dear Open Forum-

For the final printed labeling (the insert that is folded and placed inside the packaging), does it need to match the SPL version that was approved 100%?  I know the text, tables and figures need to be identical, but are sponsors allowed to add artwork, such as the company logo to the printed material, which is not included in the electronic version submitted with the application?

Thank you for your time.