As per guidance only PAS for modified release dosage form.
But, if you can justify, that it does not impact the modified release pattern of the product, then very high chances that you can go for moderate change.
I suggest to submit CBE-30 with the relevant technical data for the equivalency including dissolution profile and COAs along with risk assessment.
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Gaurang Bhavsar, MS, RAC
Associate Director - Regulatory Affairs
Micro Labs USA, Inc.
Somerset, NJ 08873
USA
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Original Message:
Sent: 25-Feb-2022 09:26
From: Mehul Govani
Subject: Imprint change
The product was already approved with a debossed imprint. The proposal is to make the change from the current debossed imprint to another debossed imprint. For example: from ABC1 TO XYZ1.
Can this still be filed as a moderate change?
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Mehul Govani RAC
Regulatory Affairs Manager
Bellerose NY
United States
Original Message:
Sent: 25-Feb-2022 00:58
From: Narayan Rao
Subject: Imprint change
Please clarify if your product already has a code imprint that was originally approved with the NDA? If so you wish to make a change to the existing approved code imprint using the same ink?
In the above case, and since its MR dosage form, I'd recommend CBE-30 i.e. moderate. Annual Report for non-MR solid dosage (i.e. IR) form
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GRSAOnline
Original Message:
Sent: 24-Feb-2022 15:59
From: Mehul Govani
Subject: Imprint change
Hi All,
If we were to change the imprint code on a modified release solid oral dosage form would this be considered major change? Is there any justification we can provide to file this as a moderate change instead?
Any help would be appreciated.
Thanks,
Mehul
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Mehul Govani RAC
Regulatory Affairs Manager
Bellerose NY
United States
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