Hi all,
Few Labeling/Technical Questions!
In the case of new marketing applications/prior approval supplements (labeling supplements), when the FDA and a company agree upon the label, would you place said final labels in section 1.14.1.3 (draft labeling text) or 1.14.2.3 (Final Labeling Text).
- At my previous life, the "final agreed label" files were placed in section 1.14.1.3 -- I never really understood why despite how strange this appeared to me.
- In my current life, we are thinking of the putting the this final agreed labels into section 1.14.2.3 (Final Labeling Text) -- this on the surface makes more sense to me.
Question 1: Does it really make a difference on where the final agreed label goes since we end up submitting an SPL later?
Lastly, upon approval of a new marketing application/supplement, it's asked to provide the SPL within 14 days of the approval letter.
- At my previous life, the SPL was placed in section 1.14.3.2 (Approved Labeling Text for Listed Drug).
- In my current life, the SPL was plopped into 1.14.2.3 (Final Labeling Text).
Question 2: Is there a specific nuance on when to use one eCTD section versus the other for the SPL file?
Question 3: If a "final" SPL is submitted prior to the approval letter received, would that eliminate the part of an approval letter that always asks to submit the SPL within 14 days of the approval letter?
Thank you all for your feedback.
Sincerely,
Sam
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Samuel Christopher Bonilla
Los Angeles CA
United States
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